Soft Cassette With Integrated Features

ABSTRACT

A soft cassette includes a body including a flexible material and first and second component. The body defines first and second lumens and first and second chambers. The first lumen extends between first and second ends. The first chamber is in the first lumen such that fluid passing through the first lumen passes through the first chamber. The second lumen is fluidly connected to the first lumen at a first junction between the first end and the first chamber and a second junction between the second end and the first chamber such that fluid passing through the second lumen bypasses the first chamber. The second chamber is in the second lumen. The first component is on a first side of the second chamber and includes a first ferromagnetic metal or magnet. The second component is on a second side of the second chamber and includes a second ferromagnetic metal magnet.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.63/318,727 filed on Mar. 10, 2022. The entire disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The present disclosure relates to a soft cassette with integratedfeatures.

BACKGROUND

This section provides background information related to the presentdisclosure which is not necessarily prior art.

There are two common methods for blood donation/collection. A firstcommon method includes obtaining whole blood donation from a donor. Oncethe whole blood is obtained a centrifugal process may be used toseparate blood components from the whole blood, for example, based onthe density of different the blood component. The desired components canbe manually, semi-automatically, or automatically moved to a collectioncontainer during and/or after application of the centrifugal forces. Asecond common method may be referred to as an apheresis collection,which requires a specialized machine. For example, the apheresis methodmay extract whole blood from a donor while the donor is connected to thespecialized apheresis machine. The whole blood may then be centrifugedto collect only the desired blood component(s) (e.g., plasma) returningall other blood components to the donor during the same donationconnection or cycle. The donor is connected to the apheresis machineduring the separation and collection of the blood component.Unfortunately, however, the apheresis process can be lengthy anduncomfortable for the donor. For example, often the donor must remainconnected to the specialized apheresis machine for an hour or more toobtain the blood component donation. Accordingly, it would be desirableto develop processes, and also to enhance the specialized apheresismachine, to improve the comfort and efficiency of the blood componentdonation procedure.

SUMMARY

This section provides a general summary of the disclosure and is not acomprehensive disclosure of its full scope or all of its features.

There is a need for a plasma or other blood component system that canreduce the donation time and increase the comfort of the donor.Embodiments presented herein can increase the efficiency of the donationprocess by using the separated blood component to push or drive thenon-desired blood components back to the donor without stopping andrestarting the centrifuge. For example, in at least one exampleembodiment, the present disclosure provides methods and apparatuses forpositioning portions, including, for example, loops, of disposables inmedical devices. In at least one example embodiment, the presentdisclosure provides systems, including, for example, surfaces, forautomatically guiding loops. In at least one example embodiment, thepresent disclosure provides medical devices, including, for example,blood separation machines, such as apheresis machines.

In at least one example embodiment, the present disclosure provides anassembly for separating a component from a multi-component fluid. Theassembly may include a filler and a loop rotational position guide. Thefiller may include a channel for holding a separation bladder of adisposable. The channel may include two opposing walls. The looprotational position guide may include a plurality of bearings. The looprotational position guide may hold a flexible loop of the disposablewhen the separation bladder is loaded in the channel. In at least oneexample embodiment, the loop rotational position guide may include astop plate. In at least one example embodiment, the flexible loop maycontact the stop plate when held in the loop rotational position guide.In at least one example embodiment, the assembly may be part of anapheresis machine. In at least one example embodiment, the assembly maybe connected to a rotor that rotates the loop rotational position guidearound an axis of rotation. In at least one example embodiment, theplurality of bearings may include a plurality of pairs of rollerbearings.

In at least one example embodiment, the present disclosure provides acentrifuge assembly. The centrifuge assembly may include a centrifugehousing having an outer surface and an internal cavity. The centrifugehousing may rotate about a rotation axis of the centrifuge assembly. Thecentrifuge assembly may include a fluid separating body disposed atleast partially within an internal cavity of the centrifuge housing. Thefluid separating body may be configured to rotate relative to thecentrifuge housing about the rotation axis of the centrifuge assembly.The centrifuge assembly may include a fluid line loop arm attached to aportion of the centrifuge housing and running along a length of theouter surface of the centrifuge housing. The fluid line loop arm mayinclude a bearing set disposed at a point along the length of the outersurface, where the bearing set is configured to contact a tubing portionof an interconnected fluid line loop and maintain the fluid line loop inan engaged position relative to the centrifuge housing while allowingthe fluid line loop to rotate in the engaged position. In at least oneexample embodiment the bearing set may include a pair of rollerbearings. In at least one example embodiment, the bearing set mayinclude a plurality of pairs of roller bearings. In at least one exampleembodiment, the centrifuge assembly may be part of an apheresis machine.In at least one example embodiment, the fluid line loop may be affixedto a static nonrotating portion of the apheresis machine at a first endof the fluid line loop via a first positively-located connector, and thefluid line loop may be interconnected to the fluid separating bodywithin the internal cavity at a second end of the fluid line loop via asecond positively-located connector. In at least one example embodiment,the second end of the fluid line loop nay rotate with the fluidseparating body. In at least one example embodiment, the fluid line loopmay be physically and fluidly attached to a disposable fluid separationbladder at the second positively-located connector. In at least oneexample embodiment, the fluid line loop may include a plurality oflumens. In at least one example embodiment, the fluid separation bladdermay include a first flexible sheet attached to a second flexible sheetforming a fluid pathway, where a first portion of the fluid pathway maybe narrow compared to a second portion of the fluid pathway.

In at least one example embodiment, the present disclosure provides amethod for automatically loading a fluid line loop into a centrifugeassembly. The method may include attaching the fluid line loop at afirst end to a fluid separating body of the centrifuge assembly androtating the fluid separating body in a first rotational directionrelative to a housing of the centrifuge assembly, where rotating thefluid separating body may cause the fluid line loop to rotate relativeto the housing and to guide into a channel of a loop arm attached to aportion of the housing. The channel may include bearings disposed in abearing set attached to the loop arm. The bearings may hold the fluidline loop in a position relative to the housing as the centrifugeassembly rotates. In at least one example embodiment, the bearings maycontact a portion of the fluid line loop as the fluid line loop rotatesinside the channel in the position relative to the housing. In at leastone example embodiment, the centrifuge housing may rotates in the firstrotational direction at a first angular velocity about a rotation axisand the fluid separating body may rotate at a different second angularvelocity about the rotation axis via a twisting force provided by thefluid line loop. In at least one example embodiment, the second angularvelocity may be substantially two times the first angular velocity. Inat least one example embodiment, the fluid line loop may be physicallyand fluidly attached to a disposable fluid separation bladder disposedat least partially within the fluid separating body. In at least oneexample embodiment, the method may further include attaching a secondend of the fluid line loop to a rotationally fixed point of an apheresismachine and rotating (for example, via a rotor and motor assembly of theapheresis machine) the centrifuge assembly about the rotation axisrelative to the rotationally fixed point of the apheresis machine.

In at least one example embodiment, the present disclosure provides amethod for collecting a blood component through apheresis. The methodmay include drawing whole blood into a centrifuge from a donor; spinningthe centrifuge to cause centrifugal force to act on the whole blood toseparate the whole blood into a least a first blood component and athird blood component; separating a first blood component from the wholeblood; extracting the first blood component into a container; detectingwhen a second blood component is being extracted; and after the secondblood component is detected and while the centrifuge continues to spin,forcing the separated first blood component back towards the centrifugeto move at least the third blood component from the centrifuge and backinto the donor. In at least one example embodiment, the first bloodcomponent may include one or more of plasma, platelets, red blood cellsand/or high hematocrit blood. In at least one example embodiment, thesecond blood component may include one or more of plasma, platelets, redblood cells and/or high hematocrit blood. In at least one exampleembodiment, the third blood component may include one or more of plasma,platelets, red blood cells and/or high hematocrit blood. In at least oneexample embodiment, the first blood component may include two or more ofplasma, platelets, red blood cells and/or high hematocrit blood. In atleast one example embodiment, the centrifuge may spin at a first speedwhen separating the first blood component from the whole blood. In atleast one example embodiment, the centrifuge may continue to spin at thefirst speed when forcing the separated first blood component backtowards the centrifuge. In at least one example embodiment, thecentrifuge may spin at a second speed when drawing whole blood into thecentrifuge from the donor. In at least one example embodiment, thesecond speed may include slower than the first speed. In at least oneexample embodiment, the first blood component may include separated fromthe whole blood in a blood component collection set that is insertedinto the centrifuge. In at least one example embodiment, the centrifugemay include a filler that spins a blood component collection bladderassociated with the blood component collection set. In at least oneexample embodiment, the blood component collection bladder may beinserted into a collection insert channel formed in the filler to holdthe blood component collection bladder.

In at least one example embodiment, the present disclosure provides anapheresis system. The apheresis system may include a first tube having alumen, fluidly associated with the needle, that moves whole blood from adonor through the lumen; a draw pump engaged with the first tube thatdraws the whole blood into a centrifuge from the donor; the centrifugethat spins to cause centrifugal force to act on the whole blood toseparate the whole blood into a least a first blood component and athird blood component; a blood component collection bladder, insertedinto the centrifuge and fluidly associated with the first tube, thatseparates the first blood component from the whole blood; a second tube,fluidly associated the blood collection bladder, that moves the firstblood component from the blood component collection bladder; acollection container, fluidly associated with the second tube, thatextracts the first blood component from the apheresis system; a sensorpositioned in physical proximity to the second tube to detect when asecond blood component is being extracted from the whole blood; andafter the second blood component is detected by the sensor and while thecentrifuge continues to spin, a return pump, engaged with the secondtube, that forces the separated first blood component back towards theblood component collection bladder through the second tube to move atleast the third blood component from the blood component collectionbladder and back into the donor. In at least one example embodiment, thefirst blood component may include plasma and the second blood componentmay include platelets, red blood cells, and/or high hematocrit blood. Inat least one example embodiment, the apheresis system may furtherinclude an anticoagulant pump configured to draw anticoagulant from ananticoagulant bag and mix the anticoagulant with whole blood at amanifold or junction fluidly associated with the first tube. In at leastone example embodiment, the centrifuge may include a filler that spinsthe blood component collection bladder. In at least one exampleembodiment, the blood component collection bladder may be inserted intoa collection insert channel formed in the filler to hold the bloodcomponent collection bladder.

In at least one example embodiment, the present disclosure provides ablood component collection set associated with an apheresis system. Theblood component collection set may include a needle inserted into ablood vessel of a donor to draw whole blood from a donor; a first tubehaving a lumen, fluidly associated with the needle, that moves the wholeblood through the lumen, where a draw pump engaged with the first tubedraws the whole blood from the donor; a blood component collectionbladder, inserted into a centrifuge and fluidly associated with thefirst tube, that separates the first blood component and a thirdcomponent from the whole blood; a second tube, fluidly associated withthe blood collection bladder, that moves the first blood component fromthe blood component collection bladder; and a collection containerfluidly associated with the second tube that extracts the first bloodcomponent from the apheresis system, where a sensor is positioned inphysical proximity to the second tube to detect when a second bloodcomponent is being extracted from the whole blood; and where, after thesecond blood component is detected by the sensor and while thecentrifuge continues to spin, a return pump engaged with the second tubeforces the separated first blood component back towards the bloodcomponent collection bladder through the second tube to move at leastthe third blood component from the blood component collection bladderand back into the donor. In at least one example embodiment, the firstblood component may include plasma and the second blood component mayinclude platelets. In at least one example embodiment, the draw pump maybe disengaged when the return pump forces the separated first bloodcomponent back towards the blood component collection bladder throughthe second tube to move at least the third blood component from theblood component collection bladder and back into the donor. In at leastone example embodiment, the blood component collection bladder may beinserted and held in a filler, in the centrifuge, that spins the bloodcomponent collection bladder. In at least one example embodiment, theblood component collection bladder may be inserted into a collectioninsert channel formed in the filler to hold the blood componentcollection bladder.

In at least one example embodiment, the present disclosure providesfiller configured for holding a separation bladder in which a componentis separated from a composite fluid. The filler may include a channelfor holding a separation bladder during separation of the component fromthe composite fluid. The channel may include a first wall and a secondwall opposite the first wall. A first end of the channel may be adjacentto a central portion of the filler and the channel spirals toward anoutside perimeter of the filler. In at least one example embodiment, atop portion of the channel may be narrower than a middle portion of thechannel. In at least one example embodiment, at least a portion of thesecond wall may have a concave surface. In at least one exampleembodiment, the second end of the channel may be located so that itexperiences a higher gravitational force during separation than thefirst end. In at least one example embodiment, the top portion of thechannel may provide reinforcement to the separation bladder duringseparation.

In at least one example embodiment, the present disclosure provides afluid separation filler. The fluid separation filler may include a bodyhaving a rotation axis substantially disposed at a mass center of thebody and a fluid collection insert channel disposed in the body andfollowing a substantially spiral path running from a first pointadjacent to the rotation axis spirally outward to a second pointdisposed adjacent to a periphery of the body. The fluid collectioninsert channel may jog outwardly toward the periphery of the body nearan end of the substantially spiral path defining a third point of thefluid collection insert channel disposed furthest from the rotationaxis. In at least one example embodiment, the fluid separation fillermay further include a fluid collection chamber disposed within the bodyand following a portion of the substantially spiral path, where thefluid collection insert channel connects to the fluid collection chamberdefining access area between an interior of the fluid collection chamberand an exterior of the body. In at least one example embodiment, thefluid collection chamber may be configured to receive a disposable fluidcollection bladder. In at least one example embodiment, a dimension fromthe rotation axis to the third point of the substantially spiral pathmay be greater than a dimension from the rotation axis to the secondpoint of the substantially spiral path. In at least one exampleembodiment, a width of the fluid collection chamber at a point along thesubstantially spiral path may be greater than a width of the fluidcollection insert channel at the point along the substantially spiralpath. In at least one example embodiment the fluid collection chambermay further include a first wall following an innermost portion of thesubstantially spiral path and a second wall substantially parallel tothe first wall and following an outermost portion of the substantiallyspiral path. In at least one example embodiment, the fluid collectionchamber may further include one or more tapered walls disposed betweenthe first wall and the second wall, and the one or more tapered wallsmay be configured to guide the disposable fluid collection bladder intoa seated position within the fluid collection chamber. In at least oneexample embodiment, a fluid inlet for the disposable fluid collectionbladder when installed in the fluid collection chamber may be disposedadjacent to the rotation axis and a first fluid path in the disposablefluid collection bladder may follow the substantially spiral pathoutwardly toward an end of the disposable fluid collection bladderdisposed adjacent to the third point of the fluid collection insertchannel disposed furthest from the rotation axis, and may fluidlyinterconnects with a second fluid path separated from the first fluidpath in the disposable fluid collection bladder running in a directionfrom the third point following the substantially spiral path inwardlytoward a fluid outlet for the disposable fluid collection bladderdisposed adjacent to the rotation axis. In at least one exampleembodiment, the fluid inlet and the fluid outlet may be part of aconnector attached to the disposable fluid collection bladder, and thebody of the fluid separation filler may include a connection point thatengages with the connector. In at least one example embodiment, theconnector may include at least one key feature, where the connectionpoint may include at least one mating key feature, and the key featuresmay positively locate the connector relative to the connection point.

In at least one example embodiment, the present disclosure provides acentrifuge assembly. The centrifuge assembly may include a centrifugehousing having an internal cavity, where the centrifuge housing rotatesabout a rotation axis of the centrifuge assembly, and a fluid separatingbody disposed at least partially within the internal cavity of thecentrifuge housing and configured to rotate relative to the centrifugehousing about the rotation axis. The fluid separating body may include afluid collection insert channel disposed in the fluid separating bodyfollowing a substantially spiral path running from a first pointadjacent to the rotation axis spirally outward to a second pointdisposed adjacent to a periphery of the fluid separating body. The fluidcollection insert channel may In at least one example embodiment, thefluid separating body may further include a fluid collection chamberdisposed within the body and following a portion of the substantiallyspiral path, where the fluid collection insert channel may connect tothe fluid collection chamber to define an access area between aninterior of the fluid collection chamber and an exterior of the fluidseparating body. In at least one example embodiment, the centrifugeassembly may further include a disposable fluid collection bladderdisposed within the fluid collection chamber following the substantiallyspiral path. The disposable fluid collection bladder may include a fluidinlet disposed adjacent to the rotation axis and a first fluid path inthe disposable fluid collection bladder may follow the substantiallyspiral path outwardly toward an end of the disposable fluid collectionbladder disposed adjacent to the third point of the fluid collectioninsert channel disposed furthest from the rotation axis and may fluidlyinterconnect with a second fluid path separated from the first fluidpath in the disposable fluid collection bladder running in a directionfrom the third point following the substantially spiral path inwardlytoward a fluid outlet for the disposable fluid collection bladderdisposed adjacent to the rotation axis. In at least one exampleembodiment, the centrifuge assembly may be part of an apheresis machine.In at least one example embodiment, the centrifuge housing may be splitinto an upper housing and a lower housing, where the upper housing mayinclude the internal cavity, the upper housing may be rotatable betweenan open state and a closed state about a pivot axis that is offset andsubstantially perpendicular to the rotation axis, and the fluidcollection insert channel of the fluid separating body may be accessiblein the open state and inaccessible in the closed state.

In at least one example embodiment, the present disclosure provides ablood component collection loop. The blood component collection loop mayinclude a flexible loop; a system static loop connector disposed at afirst end of the flexible loop, where the system static loop connectoris connected to the fixed loop connection of a centrifuge to fix thefirst end of the flexible loop to rotate in unison with the centrifuge;and a filler loop connector disposed at a second end, opposite the firstend, of the flexible loop, where the filler loop connector is connectedto a loop connection area of a filler, where torsional forces based ontwist in the flexible loop are imparted to the filler through the fillerloop connector, and where the flexible loop is rotationally moved to becaptured by a loop rotational position guide positioned on thecentrifuge. In at least one example embodiment, the blood componentcollection loop may be part of a blood component collection set, and theblood component collection set may be associated with an apheresissystem. In at least one example embodiment, the loop rotational positionguide may be attached to a rotor that rotates the loop rotationalposition guide and the flexible loop around an axis of rotation. In atleast one example embodiment, the blood component collection loop may beat least partially positioned by a loop position stop plate. In at leastone example embodiment, the flexible loop may be curved around thecentrifuge. In at least one example embodiment, the flexible loops maybe also held in position by a loop containment bracket. In at least oneexample embodiment, at least a portion of the loop rotational positionguide may include a loop twist support bearing. In at least one exampleembodiment, the loop twist support bearing may include a pair of rollerbearings. In at least one example embodiment, the loop twist supportbearing may allow the flexible loop to twist. In at least one exampleembodiment, the twist may cause the filler to rotate at a greaterangular velocity than the centrifuge. In at least one exampleembodiment, the flexible loop may include two or more lumens to movewhole blood and/or blood components within the flexible loop.

In at least one example embodiment, the present disclosure provides anassembly for loading a flexible loop. The assembly may include a looprotation position guide that includes a channel for holding a flexibleloop of a blood component collection set; a loop twist support bearing,disposed in the channel and on a portion of the loop rotation positionguide, to support the flexible loop; and a loop capture arm, where theloop capture arm may be positioned adjacent the channel and connected tothe loop rotation position guide, to guide the flexible loop into thechannel and in contact with the loop twist support bearing. In at leastone example embodiment, the assembly may be part of an apheresismachine, and the loop rotation position guide may be attached tocentrifuge that rotates the loop rotation position guide and theflexible loop around an axis of rotation. In at least one exampleembodiment the loop rotation position guide may further include a loopposition stop plate to further position the flexible loop. In at leastone example embodiment, the assembly may further include a loopcontainment bracket, positioned in a plane with the loop rotationposition guide and disposed on the centrifuge, to further capture theflexible loop.

In at least one example embodiment, the present disclosure provides amethod for automatically loading a flexible loop into an assembly. Themethod may include connecting a system static loop connector, disposedat a first end of the flexible loop, to a fixed loop connection of acentrifuge to fix the first end of the flexible loop to rotate in unisonwith the centrifuge; connecting a filler loop connector, disposed at asecond end, opposite the first end, of the flexible loop, to a loopconnection area of a filler, where torsional forces based on twist inthe flexible loop are imparted to the filler through the filler loopconnector; and rotationally moving the flexible loop into a looprotational position guide positioned on the centrifuge. In at least oneexample embodiment, the flexible loop may engage a loop twist supportbearing, disposed in a channel formed by the loop rotation positionguide, where the loop twist support bearing supports the flexible loop.In at least one example embodiment, a loop capture arm may contact theflexible loop when rotating to guide the flexible loop into the channeland in contact with the loop twist support bearing. In at least oneexample embodiment, the loop rotation position guide may further includea loop position stop plate to prevent over-rotation of the flexible looppast the channel. In at least one example embodiment, a loop containmentbracket, positioned in a plane with the loop rotation position guide anddisposed on the centrifuge, may further capture and holds the flexibleloop.

In at least one example embodiment, the present disclosure provides asoft cassette. The soft cassette may include a first cassette port, asecond cassette port, a direct flow lumen fluidly connected to the firstcassette port and the second cassette port, a drip chamberinter-disposed in the direct flow lumen such that the fluid passingthrough the direct flow lumen passes through the drip chamber, and afluid flow bypass path both fluidly connected to the direct flow lumenadjacent the first cassette port and between the first cassette port andthe drip chamber and fluidly connected to the direct flow lumen adjacentthe second cassette port and between the second cassette port and thedrip chamber, such that fluid flowing through the fluid flow bypass pathbypasses the drip chamber. In at least one example embodiment, the fluidflow bypass path may include a first bypass branch fluidly connected tothe direct flow lumen adjacent the first cassette port and a secondbypass branch fluidly connected to the direct flow lumen adjacent thesecond cassette port. In at least one example embodiment, the fluid flowbypass path may further include a fluid pressure annulus disposedbetween and fluidly connected to the first bypass branch and the secondbypass branch. In at least one example embodiment, the direct flow lumenmay include a first compliant region, disposed between a firstconnection with the first bypass branch and the drip chamber, thatallows a first fluid control valve to occlude the direct flow lumen. Inat least one example embodiment, the direct flow lumen may include asecond compliant region, disposed between a second connection with thesecond bypass branch and the drip chamber, that allows a second fluidcontrol valve to occlude the direct flow lumen. In at least one exampleembodiment the direct flow lumen may include a third compliant region,disposed in the first bypass branch, that allows a draw fluid controlvalve to occlude the first bypass branch. In at least one exampleembodiment, the first cassette port may be fluidly connected to acassette inlet tubing that moves fluid from a donor into the softcassette or fluid from the soft cassette to the donor, and the secondcassette port may be fluidly connected to a loop inlet tubing that movesfluid from a soft cassette into the centrifuge or fluid from thecentrifuge to the soft cassette. In at least one example embodiment,when drawing fluid from the donor, the fluid may pass through the fluidflow bypass path. In at least one example embodiment, when sending fluidto the donor, the fluid may pass through the direct flow lumen. In atleast one example embodiment, when drawing fluid from the donor in asubsequent draw, a portion of the fluid previously sent to the donorthrough the direct flow lumen may be maintained in the drip chamber whenthe fluid passes through the fluid flow bypass path. In at least oneexample embodiment, the soft cassette may be part of a blood componentcollection set. In at least one example embodiment, the blood componentcollection set may be part of an apheresis system.

In at least one example embodiment, the present disclosure provides ablood component collection set. The blood component collection set mayinclude a centrifuge to separate blood components from whole blood; acassette inlet tubing fluidly connected to a donor; a loop inlet tubingfluidly connected to the centrifuge; a soft cassette that includes afirst cassette port fluidly connected to the cassette inlet tubing; asecond cassette port fluidly connected to the loop inlet tubing; adirect flow lumen fluidly connected to the first cassette port and thesecond cassette port; a drip chamber inter-disposed in the direct flowlumen such that the fluid passing through the direct flow lumen passesthrough the drip chamber; and a fluid flow bypass path both fluidlyconnected to the direct flow lumen adjacent the first cassette port andbetween the first cassette port and the drip chamber and fluidlyconnected to the direct flow lumen adjacent the second cassette port andbetween the second cassette port and the drip chamber, such that fluidflowing through the fluid flow bypass path bypasses the drip chamber. Inat least one example embodiment, the fluid flow bypass path may includea first bypass branch fluidly connected to the direct flow lumenadjacent the first cassette port, a second bypass branch fluidlyconnected to the direct flow lumen adjacent the second cassette port,and a fluid pressure annulus disposed between and fluidly connected tothe first bypass branch and the second bypass branch. In at least oneexample embodiment, the direct flow lumen may include a first compliantregion, disposed between a first connection with the first bypass branchand the drip chamber, that allows a first fluid control valve to occludethe direct flow lumen, where the direct flow lumen includes a secondcompliant region, disposed between a second connection with the secondbypass branch and the drip chamber, that allows a second fluid controlvalve to occlude the direct flow lumen, and where the direct flow lumenincludes a third compliant region, disposed in the first bypass branch,that allows a draw fluid control valve to occlude the first bypassbranch. In at least one example embodiment, when drawing fluid from thedonor, the first fluid control valve and the second fluid flow controlvalve may be closed and occlude the direct flow lumen, and the drawfluid control valve may be open and allows whole blood to pass throughthe fluid flow bypass path. In at least one example embodiment, whensending fluid to the donor, the first fluid control valve and the secondfluid flow control valve may be open and allow fluid to pass through thedirect flow lumen, and the draw fluid control valve may be closed andoccludes the fluid flow bypass path. In at least one example embodiment,when drawing fluid from the donor in a subsequent draw, a portion of thefluid previously sent to the donor through the direct flow lumen may bemaintained in the drip chamber when the fluid passes through the fluidflow bypass path.

In at least one example embodiment, the present disclosure provides amethod for moving fluids through a soft cassette. The method may includeproviding a soft cassette, where the soft cassette includes a firstcassette port fluidly connected to a cassette inlet tubing, a secondcassette port fluidly connected to a loop inlet tubing, a direct flowlumen fluidly connected to the first cassette port and the secondcassette port, a drip chamber inter-disposed in the direct flow lumensuch that the fluid passing through the direct flow lumen passes throughthe drip chamber, and a fluid flow bypass path both fluidly connected tothe direct flow lumen adjacent the first cassette port and between thefirst cassette port and the drip chamber and fluidly connected to thedirect flow lumen adjacent the second cassette port and between thesecond cassette port and the drip chamber, such that fluid flowingthrough the fluid flow bypass path bypasses the drip chamber. In atleast one example embodiment, the method may include, when drawing wholeblood from a donor, receiving whole blood from the cassette inlet tubingat a first cassette port fluidly connected to the cassette inlet tubing,moving the whole blood through the fluid flow bypass path to the secondcassette port, and preventing whole blood from moving through the directlumen. In at least one example embodiment, the method may include, whenreturning red blood cells to the donor, receiving red blood cells fromthe loop inlet tubing at a second cassette port fluidly connected to theloop inlet tubing, moving the red blood cells through the direct flowlumen and the drip chamber to the first cassette port, and preventingred blood cells from moving through the fluid flow bypass path. In atleast one example embodiment, when drawing fluid from the donor in asubsequent draw, a portion of the fluid previously may be sent to thedonor through the direct flow lumen, and when returning red blood cellsto the donor.

At least one example embodiment relates to a soft cassette.

In at least one example embodiment, the soft cassette includes a body, afirst component, and a second component. The body includes a flexiblematerial. The body defines a first lumen, a first chamber, a secondlumen, and a second chamber. The first lumen extends between a first endand a second end. The first chamber is in the first lumen such thatfluid passing through the first lumen passes through the first chamber.The second lumen is fluidly connected to the first lumen at a firstjunction between the first end and the first chamber and a secondjunction between the second end and the first chamber such that fluidpassing through the second lumen bypasses the first chamber. The secondchamber in the second lumen. The first component is on a first side ofthe second chamber. The first component includes a first ferromagneticmetal or a first magnet. The second component is on a second side of thesecond chamber. The second component includes a second ferromagneticmetal or a second magnet.

In at least one example embodiment, the body includes a first side and asecond side. The first side and the second side cooperate to define thefirst lumen, the first chamber, the second lumen, and the secondchamber.

In at least one example embodiment, the body defines a first centerplane between the first side and the second side. The first chamber isreflection asymmetric about the first center plane.

In at least one example embodiment, the first chamber is reflectionasymmetric about a second center plane perpendicular to the first centerplane.

In at least one example embodiment, the body defines an orthogonalcoordinate system including a first axis, a second axis, and a thirdaxis. A center of the first chamber is offset from a center of thesecond chamber along the first axis and the second axis.

In at least one example embodiment, the body further defines a firstvalve path in the first lumen or the second lumen. The first valve pathdefines a circular cross section.

In at least one example embodiment, the body defines a first region anda second region. The second region includes the first valve path. Thefirst region defines a first thickness. The second region defines asecond thickness adjacent to the first valve path. The second thicknessis less than the first thickness.

In at least one example embodiment, the body further defines a pluralityof valve paths including the first valve path, a second valve path, anda third valve path. The first valve path is between a first end of thefirst chamber and a first end of the second lumen. The second valve pathis between a second end of the first chamber and a second end of thesecond lumen. The third valve path is between the first end of thesecond lumen and the second chamber.

In at least one example embodiment, the soft cassette further includes afilter. The filter is in the first chamber.

In at least one example embodiment, the soft cassette further includes afirst port and a second port. The first port is fluidly connected to thefirst end of the first lumen. The second port is fluidly connected tothe second end of the first lumen.

In at least one example embodiment, the first port and the second portdefine distinct shapes, colors, or both shapes and colors.

In at least one example embodiment, only one of the first port and thesecond port defines a radially-extending flange.

In at least one example embodiment, the soft cassette further includes afirst tube and a second tube. The first tube is in the first lumenbetween the first end and the first chamber. The second tube in thefirst lumen between the second end and the first chamber.

In at least one example embodiment, the soft cassette further includes afirst cover and a second cover. The first cover cooperates with the bodyto define a first pocket. The second cover cooperates with the body todefine a second pocket. The first component is in the first pocket andthe second component is in the second pocket.

In at least one example embodiment, a region between the first side ofthe second chamber and the second side of the second chamber isunobstructed. At least one of the first side of the second chamber andthe second side of the second chamber is configured to move between afirst state and a second state based on a pressure in the secondchamber.

In at least one example embodiment, in the first state, the secondchamber defines a first pressure and a first dimension is definedbetween the first component and the second component. In the secondstate, the second chamber defines a second pressure and a seconddimension is defined between the first component and the secondcomponent. The second pressure is larger than the first pressure. Thesecond dimension is larger than the first dimension.

At least one example embodiment relates to a soft cassette assembly. Thesoft cassette assembly includes a base plate, a door, a first magnet, asecond magnet, a pressure sensor, and a soft cassette. The base platedefines a plurality of receiving regions. The door is attached to thebase plate. The first magnet is coupled to the base plate. The secondmagnet is coupled to the door. The pressure sensor is in contact withthe first magnet or the second magnet. The soft cassette is configuredto be attached to the base plate. The soft cassette includes a body, afirst component, and a second component. The body defines a first lumen,a first chamber, a second lumen, and a second chamber. The first lumenextends between a first end and a second end. The first chamber is inthe first lumen such that fluid passing through the first lumen passesthrough the first chamber. The second lumen is fluidly connected to thefirst lumen at a first junction between the first end and the firstchamber and a second junction between the second end and the firstchamber such that fluid passing through the second lumen bypasses thefirst chamber. The second chamber is in the second lumen. The firstcomponent is on a first side of the second chamber. The first componentincludes a first ferromagnetic metal. The first component is configuredto be coupled to the first magnet. The second component is on a secondside of the second chamber. The second component includes a secondferromagnetic material. The second component is configured to be coupledto the second magnet.

At least one example embodiment relates to a method of manufacturing asoft cassette.

In at least one example embodiment, the method includes forming a firstside of a soft cassette body from a first thermoplastic sheet portion.The method further includes forming a second side of the soft cassettebody from a second thermoplastic sheet portion. The method furtherincludes fixing the first side to the second side to at least partiallydefine a first lumen extending between a first end and a second end, afirst chamber in the first lumen, a second lumen fluidly connected tothe first lumen at a first junction between the first end and the firstchamber and a second junction between the second end and the firstchamber, and a second chamber in the second lumen. The method furtherincludes creating the soft cassette by sealing a perimeter of the firstside and the second side.

In at least one example embodiment, the method further includes couplinga first component to the first side. The first component includes afirst ferromagnetic metal or a first magnet.

In at least one example embodiment, the coupling includes, disposing thefirst component between the first side and a cover. The disposingfurther includes fixing the cover to the first side to define a pocket.The first component is in the pocket.

In at least one example embodiment, the fixing includes radiofrequencywelding the cover to the first side around a periphery of the cover.

In at least one example embodiment, the method further includes couplinga second component to the second side. The second component includes asecond ferromagnetic metal or a second magnet.

In at least one example embodiment, the forming the first side and theforming the second side are performed concurrently.

In at least one example embodiment, the forming the first side, theforming the second side, the fixing, and the creating are performedusing radio frequency energy.

In at least one example embodiment, the forming the first side includesforming a first valve region. The first valve region has a smallerthickness than a first body region of the first side. The forming thesecond side includes forming a second valve region. The second valveregion has a smaller thickness than a second body region of the secondside. The fixing further includes at least partially defining a valvepath between at least a portion of the first valve region and at least aportion of the second valve region.

In at least one example embodiment, the method further includes, priorto the fixing, disposing a cylindrical mandrel between the first valveregion and the second valve region. The method further includes, afterthe fixing, removing the cylindrical mandrel such that the valve path isbetween the first valve region and the second valve region and the valvepath defines a circular cross section.

In at least one example embodiment, the method further includes, priorto the fixing, disposing a distinct component at least partially betweenthe first side and the second side. The distinct component includes afilter, a tube, a port, a pump, or any combination thereof. The fixingsecures the distinct component between the first side and the secondside.

In at least one example embodiment, the method further includes, priorto the fixing, folding a sheet includes the first side and the secondside such that the first side is in direct contact with the second side.

The present disclosure provides a number of advantages depending on theparticular aspect, embodiment, and/or configuration. For example, in atleast one example embodiment, the speed of rotation of the centrifugewhile moving the unneeded blood components back to the donor, theapheresis procedure may be reduced in time, for example, by about 30% ormore. This increase in efficiency may allow for faster and morecomfortable donations. With faster donation times, a donation center mayobtain more donations in a typical day, which may increase productivityand revenue. Further, donors are more likely to return to donate againif the donation is faster. Having faster donations may also allowdonation centers to attract donors using other donation centers withslower donation speeds.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations and are notintended to limit the scope of the present disclosure.

FIG. 1 shows a perspective view of an operating environment of anapheresis system in accordance with at least one example embodiment ofthe present disclosure;

FIG. 2A is a perspective view of the apheresis system shown in FIG. 1 ;

FIG. 2B is a first detail perspective view of a pump of an apheresissystem in accordance with at least one example embodiment of the presentdisclosure;

FIG. 2C is a second detail perspective view of a pump of an apheresissystem in accordance with at least one example embodiment of the presentdisclosure;

FIG. 2D is a detail perspective view of a fluid valve control system inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 3A is a detail perspective view of a disposable soft cassetteassembly in accordance with at least one embodiment of the presentdisclosure;

FIG. 3B is a perspective view of a disposable soft cassette inaccordance with at least one embodiment of the present disclosure;

FIG. 3C is an elevation section view taken through line 3C of FIG. 3B inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 3D is an elevation section view taken through line 3D of FIG. 3B inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 4A shows a perspective view of a centrifuge assembly in anapheresis system in accordance with at least one example embodiment ofthe present disclosure;

FIG. 4B shows a front perspective view of the centrifuge assembly shownin FIG. 4A;

FIG. 4C shows a rear perspective view of the centrifuge assembly shownin FIG. 4A;

FIG. 4D is a schematic section view of a centrifuge assembly in a closedstate in accordance with at least one example embodiment of the presentdisclosure;

FIG. 4E is a schematic section view of a centrifuge assembly in apartially open state in accordance with at least one example embodimentof the present disclosure;

FIG. 4F is a schematic section view of a centrifuge assembly in an openstate in accordance with at least one example embodiment of the presentdisclosure;

FIG. 4G shows a perspective view of a filler for a centrifuge inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 4H is a plan view of a filler for a centrifuge in accordance withat least one example embodiment of the present disclosure;

FIG. 4I is a schematic plan view of a substantially spiral-shapedreceiving channel for a filler in accordance with at least one exampleembodiment of the present disclosure;

FIG. 4J is an elevation section view taken through line 4J of FIG. 4H;

FIG. 4K is a detail section view of a portion of a channel in the fillerin accordance with at least one example embodiment of the presentdisclosure;

FIG. 4L shows different states of fluid collection bladders disposedinside the channel in the filler of FIG. 4K;

FIG. 5A is an illustration of a fluid component collection set includinga fluid component collection loop in accordance with at least oneexample embodiment of the present disclosure;

FIG. 5B is an illustration of the fluid component collection loop whichincludes a fluid component collection bladder in accordance with atleast one example embodiment of the present disclosure;

FIG. 5C is a cross-section illustration of the fluid componentcollection bladder in accordance with at least one example embodiment ofthe present disclosure;

FIG. 5D is another cross-section illustration of the fluid componentcollection bladder in accordance with at least one example embodiment ofthe present disclosure;

FIG. 5E shows a perspective view of a fluid component collection loop ina flexed state in accordance with at least one example embodiment of thepresent disclosure;

FIG. 5F shows a perspective view of a fluid component collection loop ina loading state in accordance with at least one example embodiment ofthe present disclosure;

FIG. 5G shows a perspective view of a fluid component collection looploaded into a filler in accordance with at least one example embodimentof the present disclosure;

FIG. 5H shows a perspective view of a fluid component collection looploaded in a filler in accordance with at least one example embodiment ofthe present disclosure;

FIG. 6A shows a schematic section view of a centrifuge assembly in afirst loop-loading state in accordance with at least one exampleembodiment of the present disclosure;

FIG. 6B shows a schematic section view of a centrifuge assembly in asecond loop-loading state in accordance with at least one exampleembodiment of the present disclosure;

FIG. 6C shows a schematic section view of a centrifuge assembly in athird loop-loading state in accordance with at least one exampleembodiment of the present disclosure;

FIG. 7A shows a schematic plan view of a centrifuge assembly in aloop-loaded state in accordance with at least one example embodiment ofthe present disclosure;

FIG. 7B shows a schematic plan view of a centrifuge assembly in anoperational state in accordance with at least one example embodiment ofthe present disclosure;

FIG. 8 is a functional diagram of an embodiment of the apheresis systemin accordance with at least one example embodiment of the presentdisclosure;

FIG. 9 is a block diagram of the electrical system of the apheresissystem in accordance with at least one example embodiment of the presentdisclosure;

FIG. 10 is a further block diagram of the electrical system of theapheresis system in accordance with at least one example embodiment ofthe present disclosure;

FIG. 11 is a further block diagram of the electrical system of theapheresis system in accordance with at least one example embodiment ofthe present disclosure;

FIG. 12A is a flowchart of a method in accordance with at least oneexample embodiment of the present disclosure;

FIG. 12B shows an apheresis system with a scanner in accordance with atleast one example embodiment of the present disclosure;

FIG. 12C shows a bottle in accordance with at least one exampleembodiment of the present disclosure;

FIG. 12D shows a graphical user interface in accordance with at leastone example embodiment of the present disclosure;

FIG. 13A is an isometric view of a plasma collection bottle holderaccording to at least one example embodiment of the present disclosure;

FIG. 13B is a flow chart according to at least one example embodiment ofthe present disclosure;

FIG. 14A is a perspective view of a moving loop holder of an apheresissystem in accordance with at least one example embodiment of the presentdisclosure;

FIG. 14B is a partial view of the moving loop holder illustrated in FIG.14A;

FIG. 14C is an elevation cross-sectional view along line 14C illustratedin FIG. 14B;

FIG. 14D is a partial view of the moving loop holder in an extendedposition in accordance with at least one example embodiment of thepresent disclosure;

FIG. 14E is a partial view of the moving loop holder in a retractedposition in accordance with at least one example embodiment of thepresent disclosure;

FIG. 14F is a partial view of the moving loop holder in the retractedposition and the lid of a centrifuge assembly in the apheresis system isin an open position in accordance with at least one example embodimentof the present disclosure;

FIG. 15A is a perspective view of a load cell assembly in accordancewith at least one example embodiment of the present disclosure;

FIG. 15B is an exploded perspective view of the load cell assembly ofFIG. 15A in accordance with at least one example embodiment of thepresent disclosure;

FIG. 15C is a top perspective view of a mount plate of the load cellassembly of FIG. 15A in accordance with at least one example embodimentof the present disclosure;

FIG. 15D is a bottom perspective view of the mount plate of FIG. 15C inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 15E is a perspective view of a bracket of the load cell assembly ofFIG. 15A in accordance with at least one example embodiment of thepresent disclosure;

FIG. 15F is a perspective view of a load cell of the load cell assemblyof FIG. 15A in accordance with at least one example embodiment of thepresent disclosure;

FIG. 15G is a perspective view of a load interface plate of the loadcell assembly of FIG. 15A in accordance with at least one exampleembodiment of the present disclosure;

FIG. 15H is a perspective view of an overload support bar of the loadcell assembly of FIG. 15A in accordance with at least one exampleembodiment of the present disclosure;

FIG. 15I is a partial sectional view of the load cell assembly of FIG.15A in an engaged state in accordance with at least one exampleembodiment of the present disclosure;

FIG. 15J is a partial sectional view of the load cell assembly of FIG.15A in a disengaged state, with a portion of a first magnet cut away, inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 15K is a side elevation view of a cradle of the load cell assemblyof FIG. 15A in accordance with at least one example embodiment of thepresent disclosure;

FIG. 15L is a front elevation view of the cradle of FIG. 15K inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 15M is perspective view of a vessel in the cradle of FIG. 15K inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 16A is a flowchart of a method in accordance with at least oneexample embodiment of the present disclosure;

FIG. 16B shows an apheresis system connected to a network in accordancewith at least one example embodiment of the present disclosure;

FIG. 16C shows a graphical user interface in accordance with at leastone example embodiment of the present disclosure;

FIG. 16D is a block diagram of a computing system in accordance with atleast one example embodiment of the present disclosure;

FIG. 17A is a flowchart of a method in accordance with at least oneexample embodiment of the present disclosure;

FIG. 17B shows an apheresis system in accordance with at least oneexample embodiment of the present disclosure;

FIGS. 17C-17E show output devices in accordance with at least oneexample embodiment of the present disclosure;

FIG. 18A is a partially exploded perspective view of an apheresis systemincluding modular serviceability sleds in accordance with at least oneexample embodiment of the present disclosure;

FIG. 18B is a schematic elevation section view of a modularserviceability sled in a disengaged state from a base of the apheresissystem in accordance with at least one example embodiment of the presentdisclosure;

FIG. 18C is a bottom perspective view of a return pump assembly of theapheresis system of FIG. 18A in accordance with at least one exampleembodiment of the present disclosure;

FIG. 18D is a schematic elevation section view of the modularserviceability sled of FIG. 18C in an engaged state with the base ofapheresis system in accordance with at least one example embodiment ofthe present disclosure;

FIG. 18E is a flowchart illustrating a method of servicing an apheresissystem in accordance with at least one example embodiment of the presentdisclosure;

FIG. 19A is a perspective view of a collection bottle in accordance withat least one example embodiment of the present disclosure;

FIG. 19B is an elevated view of the collection bottle of FIG. 19Aoriented in a plasma collection cradle of the apheresis system inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 19C is a perspective view of the canister of the collection bottleof FIG. 19A;

FIG. 19D is a top-down perspective view of the lid of the collectionbottle of FIG. 19A;

FIG. 19E is a bottom-up view of the lid of the collection bottle of FIG.19A;

FIG. 19F is a partial, cross-sectional view of the collection bottle ofFIG. 19A prior to collection (i.e., prior to use) in accordance with atleast one example embodiment of the present disclosure;

FIG. 19G is a partial view of the collection bottle of FIG. 19A aftercollection (i.e. after use) in accordance with at least one exampleembodiment of the present disclosure;

FIG. 19H is an elevation view of a collection bottle transport packageincluding multiple rows of filled collection bottles (i.e., aftercollection) in accordance with at least one example embodiment of thepresent disclosure;

FIG. 19I is side view of the collection bottle of FIG. 19A disposed in acollection cradle in accordance with at least one example embodiment ofthe present disclosure;

FIG. 19J is a perspective view of the collection bottle of FIG. 19Adisposed in the collection cradle;

FIG. 20 is a flowchart of a method in accordance with at least oneexample embodiment of the present disclosure;

FIG. 21A is a partial perspective view of the apheresis system of FIG.18A in accordance with at least one example embodiment of the presentdisclosure;

FIG. 21B is an elevation view of a first hanger assembly of theapheresis system of FIG. 21A in accordance with at least one exampleembodiment of the present disclosure;

FIG. 21C is an exploded perspective view of the first hanger assembly ofFIG. 21B in accordance with at least one example embodiment of thepresent disclosure;

FIG. 21D is an elevation view of a second hanger assembly of theapheresis system of FIG. 21A in accordance with at least one exampleembodiment of the present disclosure;

FIG. 21E is an exploded perspective view of the second hanger assemblyof FIG. 21D in accordance with at least one example embodiment of thepresent disclosure;

FIG. 21F is a perspective view of an air assembly of the apheresissystem of FIG. 21A in accordance with at least one example embodiment ofthe present disclosure;

FIG. 21G is a partial perspective view of a centrifuge housing of theapheresis system of FIG. 21A in accordance with at least one exampleembodiment.

FIG. 21H is a perspective view of a centrifuge assembly of the apheresissystem of FIG. 21A in a cover lock state in accordance with at least oneexample embodiment of the present disclosure;

FIG. 21I is partial exploded perspective view of a latch engagementplate and a latch assembly of the centrifuge of FIG. 21H in accordancewith at least one example embodiment of the present disclosure;

FIG. 21J is a perspective view of a cover engagement plate of thecentrifuge assembly of FIG. 21H in accordance with at least one exampleembodiment of the present disclosure;

FIG. 21K is a perspective view of a cover of the centrifuge assembly ofFIG. 21H in accordance with at least one example embodiment of thepresent disclosure;

FIG. 21L is a perspective view of a base of the centrifuge assembly ofFIG. 21H in accordance with at least one example embodiment of thepresent disclosure;

FIG. 21M is partial bottom perspective view of the centrifuge assemblyof FIG. 21H in the latched state in accordance with at least one exampleembodiment of the present disclosure;

FIG. 21N is partial bottom perspective view of the centrifuge assemblyof FIG. 21M in the unlatched state in accordance with at least oneexample embodiment of the present disclosure;

FIG. 21O is a perspective view of the compressor assembly of FIG. 21H ina cover unlock state in accordance with at least one example embodimentof the present disclosure;

FIG. 22A is a flowchart of a method in accordance with at least oneexample embodiment of the present disclosure;

FIG. 22B is a flowchart of a method in accordance with at least oneexample embodiment of the present disclosure;

FIG. 22C shows a centrifugal chamber in accordance with at least oneexample embodiment of the present disclosure;

FIG. 23A is an elevation section view of a flexure-based tubing statesensor in accordance with at least one example embodiment of the presentdisclosure;

FIG. 23B is a perspective view of the flexure block of the flexure-basedtubing state sensor of FIG. 23A;

FIG. 23C is a schematic diagram of an exaggerated displacement of theflexure block when a pressure is applied to a tubing section engagedwith the flexure block of FIG. 23B;

FIG. 23D is a perspective view of another example of the flexure blockof the flexure-based tubing state sensor in accordance with at least oneexample embodiment of the present disclosure;

FIG. 24A is an elevation view of the blood component collection loop ofFIG. 5A in accordance with examples of the present disclosure;

FIG. 24B is an elevation view of the blood component collection loop ofFIG. 24A in a first folded state in accordance with at least one exampleembodiment;

FIG. 24C is an elevation view of the blood component collection loop ofFIG. 24A in a second folded state in accordance with at least oneexample embodiment;

FIG. 24D is an elevation view of the blood component collection loop ofFIG. 24A in a third folded state in accordance with at least one exampleembodiment;

FIG. 24E is a bottom plan view of the blood component collection loopwith a folded and packaged bladder in accordance with at least oneexample embodiment of the present disclosure;

FIG. 24F is a perspective view of the blood component collection set ofFIG. 5A in accordance with at least one example embodiment;

FIG. 24G is a perspective view of the blood component collection loop ofFIG. 24F without seal tape wrap in accordance with at least one exampleembodiment;

FIG. 24H is a top plan view of the blood component collection loop ofFIG. 24A in accordance with at least one example embodiment;

FIG. 24I is a perspective view of a filler of the centrifuge assembly ofFIG. 4B in accordance with at least one example embodiment of thepresent disclosure;

FIG. 24J is a detail schematic plan view of a section of a collectioninsert channel of the centrifuge assembly of FIG. 24I in accordance withat least one example embodiment;

FIG. 25A is a perspective view of another soft cassette in accordancewith at least one example embodiment of the present disclosure;

FIG. 25B is a side elevation view of the soft cassette of FIG. 25A inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 25C is a front elevation view of the soft cassette of FIG. 25A inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 25D is a schematic sectional view of a soft cassette assemblyincluding the soft cassette of FIG. 25A in accordance with at least oneexample embodiment of the present disclosure;

FIG. 25E is a perspective view of the soft cassette assembly of FIG. 25Din an open state in accordance with at least one example embodiment ofthe present disclosure;

FIG. 25F is a partial sectional view of the soft cassette of FIG. 25A ina first pressure state in accordance with at least one exampleembodiment of the present disclosure;

FIG. 25G is a partial sectional view of the soft cassette of FIG. 25A ina second pressure state in accordance with at least one exampleembodiment of the present disclosure;

FIG. 25H is an exploded view of the soft cassette of FIG. 25A inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 25I is another exploded view of the soft cassette of FIG. 25A inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 25J is a flowchart depicting a method of manufacturing the softcassette of FIG. 25A in accordance with at least one example embodimentof the present disclosure;

FIG. 25K is a partial sectional view of the soft cassette of FIG. 25Ashowing a valve region in accordance with at least one exampleembodiment of the present disclosure.

FIG. 25L is a detail sectional view of the valve region of FIG. 25K inaccordance with at least one example embodiment of the presentdisclosure;

FIG. 25M is a schematic view of another soft cassette in accordance withat least one example embodiment of the present disclosure;

FIG. 26A is a perspective view of a separation set in a packaged statein accordance with at least one example embodiment of the presentdisclosure;

FIG. 26B is an elevation view of the separation set of FIG. 26A in thepackaged configuration in accordance with at least one exampleembodiment of the present disclosure;

FIG. 26C is a schematic view of a separation assembly including theseparation set of FIG. 26A in accordance with at least one exampleembodiment of the present disclosure;

FIG. 26D is a schematic view of an apheresis system including a properlyinstalled component collection assembly in accordance with at least oneexample embodiment of the present disclosure;

FIG. 26E is a partial perspective view of a valve housing of theapheresis system of FIG. 26D in accordance with at least one exampleembodiment of the present disclosure;

FIG. 26F is a schematic view of an apheresis system including animproperly installed component collection assembly in accordance with atleast one example embodiment of the present disclosure;

FIG. 26G is a schematic view of an AC bag of the separation assembly ofFIG. 26C in accordance with at least one example embodiment of thepresent disclosure;

FIG. 26H is a schematic view of a saline bag of the separation assemblyof FIG. 26C in accordance with at least one example embodiment of thepresent disclosure;

FIG. 26I is perspective view of a vessel in a cradle of the apheresissystem of FIG. 26D in accordance with at least one example embodiment ofthe present disclosure; and

FIG. 26J is a side elevation view of the vessel and cradle of FIG. 26Iin accordance with at least one example embodiment of the presentdisclosure.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

Example embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, and methods, to provide a thoroughunderstanding of embodiments of the present disclosure. It will beapparent to those skilled in the art that specific details need not beemployed, that example embodiments may be embodied in many differentforms and that neither should be construed to limit the scope of thedisclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail.

The terminology used herein is for the purpose of describing particularexample embodiments only and is not intended to be limiting. As usedherein, the singular forms “a,” “an,” and “the” may be intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. The terms “comprises,” “comprising,” “including,” and“having” are inclusive and therefore specify the presence of statedfeatures, integers, steps, operations, elements, and/or components, butdo not preclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. The method steps, processes, and operations described hereinare not to be construed as necessarily requiring their performance inthe particular order discussed or illustrated, unless specificallyidentified as an order of performance. It is also to be understood thatadditional or alternative steps may be employed.

When an element or layer is referred to as being “on,” “engaged to,”“connected to,” or “coupled to” another element or layer, it may bedirectly on, engaged, connected, or coupled to the other element orlayer, or intervening elements or layers may be present. In contrast,when an element is referred to as being “directly on,” “directly engagedto,” “directly connected to,” or “directly coupled to” another elementor layer, there may be no intervening elements or layers present. Otherwords used to describe the relationship between elements should beinterpreted in a like fashion (e.g., “between” versus “directlybetween,” “adjacent” versus “directly adjacent,” etc.). As used herein,the term “and/or” includes any and all combinations of one or more ofthe associated listed items.

Although the terms first, second, third, etc. may be used herein todescribe various elements, components, regions, layers, and/or sections,these elements, components, regions, layers, and/or sections should notbe limited by these terms. These terms may be only used to distinguishone element, component, region, layer or section from another region,layer, or section. Terms such as “first,” “second,” and other numericalterms when used herein do not imply a sequence or order unless clearlyindicated by the context. Thus, a first element, component, region,layer, or section discussed below could be termed a second element,component, region, layer, or section without departing from theteachings of the example embodiments.

Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,”“lower,” “above,” “upper,” and the like, may be used herein for ease ofdescription to describe one element or feature's relationship to anotherelement(s) or feature(s) as illustrated in the figures. Spatiallyrelative terms may be intended to encompass different orientations ofthe device in use or operation in addition to the orientation depictedin the figures. For example, if the device in the figures is turnedover, elements described as “below” or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.Thus, the example term “below” can encompass both an orientation ofabove and below. The device may be otherwise oriented (rotated 90degrees or at other orientations) and the spatially relative descriptorsused herein interpreted accordingly.

Various components are referred to herein as “operably associated.” Asused herein, “operably associated” refers to components that are linkedtogether in operable fashion and encompasses embodiments in whichcomponents are linked directly, as well as embodiments in whichadditional components are placed between the linked components.“Operably associated” components can be “fluidly associated.” “Fluidlyassociated” refers to components that are linked together such thatfluid can be transported between them. “Fluidly associated” encompassesembodiments in which additional components are disposed between the twofluidly associated components, as well as components that are directlyconnected. Fluidly associated components can include components that donot contact fluid, but contact other components to manipulate the system(e.g., a peristaltic pump that pumps fluids through flexible tubing bycompressing the exterior of the tube).

The term “donor,” as used herein, can mean any person providing a fluid(e.g., whole blood) to the apheresis system. A donor can also be apatient that also provides a fluid to the apheresis system temporarilywhile the fluid is processed, treated, manipulated, etc. before beingprovided back to the patient.

The term “automatic” and variations thereof, as used herein, refers toany process or operation done without material human input when theprocess or operation is performed. However, a process or operation canbe automatic, even though performance of the process or operation usesmaterial or immaterial human input, if the input is received beforeperformance of the process or operation. Human input is deemed to bematerial if such input influences how the process or operation will beperformed. Human input that consents to the performance of the processor operation is not deemed to be “material”.

The term “computer-readable medium” as used herein refers to anytangible storage and/or transmission medium that participates inproviding instructions to a processor for execution. Such a medium maytake many forms, including but not limited to, non-volatile media,volatile media, and transmission media. Non-volatile media includes, forexample, NVRAM, or magnetic or optical disks. Volatile media includesdynamic memory, such as main memory. Common forms of computer-readablemedia include, for example, a floppy disk, a flexible disk, hard disk,magnetic tape, or any other magnetic medium, magneto-optical medium, aCD-ROM, any other optical medium, punch cards, paper tape, any otherphysical medium with patterns of holes, a RAM, a PROM, and EPROM, aFLASH-EPROM, a solid state medium like a memory card, any other memorychip or cartridge, a carrier wave as described hereinafter, or any othermedium from which a computer can read. A digital file attachment toe-mail or other self-contained information archive or set of archives isconsidered a distribution medium equivalent to a tangible storagemedium. When the computer-readable media is configured as a database, itis to be understood that the database may be any type of database, suchas relational, hierarchical, object-oriented, and/or the like.Accordingly, the disclosure is considered to include a tangible storagemedium or distribution medium and prior art-recognized equivalents andsuccessor media, in which the software implementations of the presentdisclosure are stored.

The term “module” as used herein refers to any known or later developedhardware, software, firmware, artificial intelligence, fuzzy logic, orcombination of hardware and software that is capable of performing thefunctionality associated with that element.

The terms “determine”, “calculate” and “compute,” and variationsthereof, as used herein, are used interchangeably and include any typeof methodology, process, mathematical operation or technique.

Embodiments of the present disclosure will be described more fully withreference to the accompanying drawings and in connection with apheresismethods and systems. Embodiments below may be described with respect toseparating blood components from whole blood. However, the exampleprocedures are provided simply for illustrative purposes. It is notedthat the embodiments are not limited to the description below. Theembodiments are intended for use in products, processes, devices, andsystems for separating any composite liquid. Accordingly, the presentdisclosure is not limited to separation of blood components from wholeblood.

Referring to FIG. 1 , a perspective view of an operating environment 100of an apheresis system 200 is shown in accordance with at least oneexample embodiment of the present disclosure. The operating environment100 may include an apheresis system 200, a donor 102, and one or moreconnections (e.g., donor feed tubing 104, cassette inlet tubing 108A,anticoagulant tubing 110, etc.) running from the donor 102 to theapheresis system 200, and/or vice versa. As shown in FIG. 1 , the donorfeed tubing 104 may be fluidly connected with at least one blood vessel,for example, a vein, of the donor 102 via venipuncture. For example, acannula connected to an end of the donor feed tubing 104 may be insertedthrough the skin of the donor 102 and into a target site, or vein. Thisconnection may provide an intravenous path for blood to flow from thedonor 102 to the apheresis system 200, and/or for blood components toflow back to the donor 102. In at least one example embodiment, thefluid paths and connections may form an extracorporeal tubing circuit ofthe apheresis system 200.

Blood supplied from the donor 102 may flow along the donor feed tubing104 through a tubing connector 106 and along the cassette inlet tubing108A into a soft cassette assembly 300. The soft cassette assembly 300may include one or more fluid control paths and valves for selectivelycontrolling the flow of blood to and/or from the donor 102. Theapheresis system 200 may include an anticoagulant supply contained in ananticoagulant (AC) bag 114. The anticoagulant may be pumped at leastthrough the anticoagulant tubing 110 and the tubing connector 106preventing the coagulation of blood in the apheresis system 200.

Anticoagulants can include one or more of, but are not limited to,citrate and/or unfractionated heparin. The AC bag 114 and other bags orbottles described herein can be made from, for example, one or more of,but not limited to: polyvinyl chloride (PVC), plasticized-PVC,polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone,thermoplastics, thermoplastic elastomer, polymers, copolymers, and/orcombinations thereof. The volume of AC in the AC bag 114 may vary basedon the various factors, including the mass of the donor 102, thevolumetric flow of blood from the donor, etc. In one example, the volumein the AC bag 114 may be 250 to 500 mL, although the volume in the ACbag 114 may be more or less than this volume.

In at least one example embodiment, the apheresis system 200 may includea plasma collection bottle 122, or container, a saline fluid containedin a saline bag 118, and one or more lines or tubes such as salinetubing 116 and plasma tubing 120 (e.g., fluid conveying tubing, etc.)connecting the saline bag 118 and the plasma collection bottle 122 withthe extracorporeal tubing circuit of the apheresis system 200. Theamount of saline provided in the saline bag 118 can be 500 to 800 mL,although the volume in the saline bag 118 may be more or less than thisvolume. An example donation of a blood component (e.g., plasma) may be880 mL. Thus, the plasma collection bottle 122 may hold at least thisamount of plasma. In at least one example embodiment, the plasmacollection bottle 122 may include a connection point disposed at,adjacent to, or in physical proximity to, a substantially bottommostportion of the plasma collection bottle 122 (e.g., when the plasmacollection bottle 122 is installed in a plasma collection cradle 232C,as shown in FIG. 2A). The connection point may include one or moreconnectors that are configured to interconnect with the plasma tubing120 to receive and/or convey plasma. The disposition of the connectionpoint at the bottom of the plasma collection bottle 122 can allow plasmacontained in the plasma collection bottle 122 to move out of the plasmatubing 120 back through the lines, as described herein, without trappingair bubbles, etc. In at least one example embodiment, the plasmacollection bottle 122 may be configured as a flexible bag, rigidcontainer, and/or other container, and thus, the plasma collectionbottle 122 is not limited to bottles or bottle-like containers.

FIG. 2A shows a perspective view of the apheresis system 200 describedin FIG. 1 . The apheresis system 200 may provide for a continuous wholeblood separation process. In at least one example embodiment, wholeblood may be withdrawn from a donor 102 and substantially continuouslyprovided to a blood component separation device of the apheresis system200 where the blood may be separated into various components and atleast one of these blood components may be collected from the apheresissystem 200. In at least one example embodiment, one or more of theseparated blood components may be either collected, for subsequent use,or returned to the donor 102. The blood may be withdrawn from the donor102 and directed into a centrifuge of the apheresis system 200 throughan opening 220 in an access panel 224 of the apheresis system 200. In atleast one example embodiment, the tubing the donor feed tubing 104, thecassette inlet tubing 108A, inlet tubing 108B (also referred to hereinas loop inlet tubing 108B), exit tubing 112 (also referred to herein asloop exit tubing 112), the saline tubing 116, and the plasma tubing 120,used in the extracorporeal tubing circuit may together define a closed,sterile, and disposable system, or blood component collection set, whichmay be further described hereinafter.

Examples of apheresis, plasmapheresis, and other separation systems thatmay be used with embodiments of the present disclosure (e.g., asapheresis system 200) include, but are not limited to, the SPECTRAOPTIA® apheresis system, COBE® spectra apheresis system, and the TRIMAACCEL® automated blood collection system, all manufactured by TerumoBCT, of Lakewood, Colo.

Operation of the various pumps, valves, and blood component separationdevice, or centrifuge, may be controlled by one or more processorsincluded in the apheresis system 200, and may advantageously comprise aplurality of embedded computer processors that are part of a computersystem. The computer system may also include components that allow auser to interface with the computer system, including for example,memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magneticdrives, optical drives, flash memory, etc.); communication/networkingdevices (e.g., wired such as modems/network cards, or wireless such asWi-Fi); input devices such as keyboard(s), touch screen(s), camera(s),and/or microphone(s); and output device(s) such as display(s), and audiosystem(s), etc. To assist the operator of the apheresis system 200 withvarious aspects of its operation, in at least one example embodiment theblood component separation device, or centrifuge, may include agraphical user interface with a display that includes an interactivetouch screen.

The apheresis system 200 may include a housing 204 and/or structuralframe, a cover 210, an access panel 224 disposed at a front 202 and/orrear 206 of the apheresis system 200, and one or more supports 232A-232Cincluding hooks, rests, cradles, arms, protrusions, plates, and/or othersupport features for holding, cradling, and/or otherwise supporting acontainer or the AC bag 114, the saline bag 118, or the plasmacollection bottle 122. In at least one example embodiment, the featuresof the apheresis system 200 may be described with reference to acoordinate system 103 and/or one or more axes thereof. The housing 204may include a machine frame (e.g., made of welded, bolted, and/orconnected structural elements, extruded material, beams, etc.) to whichone or more panels, such as the cover 210, doors, subassemblies, and/orcomponents are attached. In at least one example embodiment, at leastone panel of the apheresis system 200 may include a mounting surface forthe soft cassette assembly 300, one or more pumps such as a draw pump208, a return pump 212, or an anticoagulant (AC) pump 216, and/or afluid valve control system 228 (e.g., plasma and saline valve control,etc.).

The access panel 224 may include one or more handles, locks, and apivoting or hinged axis 226 (e.g., a door hinge, piano hinge, continuoushinge, cleanroom hinge, etc.). In any event, the access panel 224 may beselectively opened to provide access to an interior of the apheresissystem 200, and more specifically to a blood separation assembly, orcentrifuge. In at least one example embodiment, the access panel 224 mayprovide access to load and/or unload the centrifuge with one or morecomponents in the blood component collection set. Details of thecentrifuge are described in greater detail at least with respect toFIGS. 4A-4L below.

The inside of the apheresis system 200 may be separated into at least acentrifuge portion and a controls portion. For instance, the centrifugeportion may include a cavity configured to receive the centrifuge,rotation motor, and associated hardware. This area may be physicallyseparated from the controls portion via one or more walls of the cavity.In at least one example embodiment, access to the controls portion(e.g., configured to house or otherwise contain the motor controller,CPU or processor(s), electronics, wiring, etc.) may be provided via asecurely fastened panel of the housing 204, and/or panel separate fromthe access panel 224.

In at least one example embodiment, the apheresis system 200 may includea number of pumps, such as the draw pump 208, the return pump 212, orthe AC pump 216, configured to control the flow of fluid (e.g., bloodand/or blood components, anticoagulant, saline, etc.) through theapheresis system 200. For instance, the apheresis system 200 may includethe draw pump 208 that controls blood flow to and/or from the donor 102into the centrifuge of the apheresis system 200. The draw pump 208 mayengage with a portion of the inlet tubing 108B disposed between the softcassette assembly 300 and the centrifuge of the apheresis system 200. Inat least one example embodiment, the apheresis system 200 may includethe return pump 212 configured to control a flow of separated bloodcomponents (e.g., plasma, etc.) from the centrifuge to a plasmacollection bottle 122 and/or vice versa. Additionally or alternatively,the return pump 212 may control a flow of saline (e.g., supplied fromthe saline bag 118) throughout the blood component collection set and/orapheresis system 200. The AC pump 216 may engage with a portion of theanticoagulant tubing 110 to selectively control the flow ofanticoagulant throughout the blood component collection set of theapheresis system 200. As shown in FIG. 2A, the draw pump 208, the returnpump 212, and the AC pump 216 can be disposed at least partially on atop portion of the cover 210 of the apheresis system 200.

FIGS. 2B and 2C show various perspective views of the draw pump 208, thereturn pump 212, or the AC pump 216 of the apheresis system 200 inaccordance with at least one example embodiment of the presentdisclosure. Although the draw pump 208 is shown and described inconjunction with FIGS. 2B and 2C, it should be appreciated that theother pump assemblies of the apheresis system 200, i.e., the return pump212 and the AC pump 216, may be different and operate differently insome particulars; however, in many instances the return pump 212 and/orthe AC pump 216 may be or may include a substantially similar, if notidentical, construction to the draw pump 208 described.

The draw pump 208 may include a pump cover 236 or housing configured toat least partially enclose the moving elements of the draw pump 208. Inat least one example embodiment, the pump cover 236 may include a hingedtubing guard door sub-assembly or a tubing guard 240 that is configuredto open and close about a tubing guard pivot axis 242. In at least oneexample embodiment, the tubing guard 240 may be attached to the pumpcover 236 via one or more fasteners disposed along the tubing guardpivot axis 242. As shown in FIGS. 2B and 2C, blood provided by the donor102 may be conveyed, or drawn, by the draw pump 208 into a centrifuge ina first draw or centrifuge direction 250A. Additionally oralternatively, blood or other fluid may be conveyed, or drawn, by thedraw pump 208 toward the donor 102 in a donor direction 250B, oppositethe centrifuge direction 250A.

In at least one example embodiment, the draw pump 208 and/or the returnpump 212 and the AC pump 216 may be a tubing pump, peristaltic pump,diaphragm pump, and/or other pump configured to manipulate the flow offluid (e.g., blood, blood components, anticoagulant, saline, etc.) in atleast a portion of tubing. For example, the draw pump 208, the returnpump 212, or the AC pump 216 may include a motor operativelyinterconnected with a rotating tubing contact assembly. In operation,the tubing (e.g., the inlet tubing 108B, the exit tubing 112, theanticoagulant tubing 110, etc.) may be inserted into a lead tubing guide244, a tubing pressure block 248, and an end tubing guide 252 adjacentto a rotating tubing contact head. In at least one example embodiment,the tubing pressure block 248 may be moved in a direction away from therotating tubing contact head of the draw pump 208, the return pump 212,or the AC pump 216 providing a loading clearance area, or vice versa.The rotating tubing contact head may comprise a number of rotarypressure rollers 268 configured to rotate about respective pressureroller rotation axes 264. Each of the rotary pressure rollers 268 may bedisposed between a first rotary pump plate 272A and a second rotary pumpplate 272B, where the first rotary pump plate 272A and the second rotarypump plate 272B are configured to rotate about a pump rotation axis 260.In at least one example embodiment, the rotary pressure rollers 268 maybe disposed at a periphery of the first rotary pump plate 272A and thesecond rotary pump plate 272B.

The one or more of the draw pump 208, the return pump 212, or the ACpump 216 may include, or operate similarly to, the Pulsafeeder® modelUX-74130 peristaltic pump, Pulsafeeder® MEC-O-MATIC series of pumps, allmanufactured by Pulsafeeder Inc., of Punta Gorda, Fla., withoutlimitation. Other examples of the draw pump 208, the return pump 212, orthe AC pump 216 may include, but are in no way limited to, the INTEGRADOSE IT laboratory peristaltic pump manufactured by INTEGRA BiosciencesAG, of Switzerland, and WELCO WP1200, WP1100, WP1000, WPX1, and/or WPMseries of peristaltic pumps all manufactured by WELCO Co., Ltd., ofTokyo, Japan.

Once the tubing is loaded into the lead tubing guide 244, the tubingpressure block 248, and/or the end tubing guide 252, at least some ofthe rotary pressure rollers 268 may be caused to engage with, contact,or otherwise compress the tubing disposed between the rotating tubingcontact head and the tubing pressure block 248. As the first rotary pumpplate 272A and the second rotary pump plate 272B rotate about the pumprotation axis 260 the rotary pressure rollers 268 may compress a portionof the tubing between the draw pump 208, the return pump 212, or the ACpump 216 and the tubing pressure block 248 positively displacing fluidinside the portion of the tubing in a particular direction such as thecentrifuge direction 250A or the donor direction 250B as the rotarypressure rollers 268 move. For instance, as the first rotary pump plate272A and the second rotary pump plate 272B rotate in a counterclockwisedirection about the pump rotation axis 260, the rotation of the rotarypressure rollers 268 compressing the tubing between the rotary pressurerollers 268 and the tubing pressure block 248 may displace, or pump,fluid in the centrifuge direction 250A. As another example, as the firstrotary pump plate 272A and the second rotary pump plate 272B rotate in aclockwise direction about the pump rotation axis 260, the rotation ofthe rotary pressure rollers 268 compressing the tubing between therotary pressure rollers 268 and the tubing pressure block 248 maydisplace, or pump, fluid in the donor direction 250B. When not activelypumping, the pump 208 can be maintained in a state where at least one ofthe rotary pressure rollers 268 continues to occlude the inlet tubing108B (normally closed or NC) or in a state where none of the rotarypressure rollers 268 occludes the inlet tubing 108B (normally open orNO). Thus, the draw pump 208, based on the state when motionless, canalso act as a “valve” to prevent or allow fluid movement. This abilitymay also be available with the return pump 212 and/or the AC pump 216.

The tubing guard 240 and the pump cover 236 may serve to protect anoperator (e.g., phlebotomist, apheresis technician, etc.) and/or thedonor 102 from incidental contact with one or more moving parts of thedraw pump 208, the return pump 212, or the AC pump 216. In at least oneexample embodiment, the tubing guard 240 may be held in a closedposition via one or more guard closure features 254 disposed in or inoperative relation to the tubing guard 240, the lead tubing guide 244,the tubing pressure block 248, and/or the end tubing guide 252. In somecases, these guard closure features 254 may be magnets contained in thetubing guard 240, the lead tubing guide 244, tubing pressure block 248,and/or the end tubing guide 252. In at least one example embodiment, thedraw pump 208, the return pump 212, or the AC pump 216 may be stopped orprevented from moving/operating when the tubing guard 240 is open. In atleast one example embodiment, a door closure sensor may be included inthe guard closure features 254, the lead tubing guide 244, the endtubing guide 252, and/or the tubing pressure block 248.

One or more fluid control valves may be used to control the routing orflow direction of fluid conveyed throughout the tubing of the apheresissystem 200. In at least one example embodiment, the apheresis system 200may include a plasma and saline valve control system such as the fluidvalve control system 228 disposed adjacent to the saline bag 118 and/orthe plasma collection bottle 122. The fluid valve control system 228 isshown in the detailed perspective view of FIG. 2D.

As shown in FIG. 2D, the exit tubing 112 may pass through the returnpump 212 and interconnect with a saline and plasma tubing y-connector280. The saline and plasma tubing y-connector 280 may allow connectionof the exit tubing 112 to a saline tubing 116 line and a plasma tubing120 line. The fluid valve control system 228 may include an airdetection sensor 284 disposed at a first end of the saline and plasmavalve housing 276 and surrounding a portion of the exit tubing 112. Theair detection sensor 284 can be any light, ultrasonic, or other type ofsensor that can detect the presence of fluid or air in the exit tubing112 and provide that signal to a controller of the apheresis system 200.Types of air detection sensors 284 may include, for example, theSONOCHECK ABD05, made by SONOTEC US Inc., or another similar sensor.

The saline and plasma valve housing 276 may include a number ofreceiving features (e.g., grooves, channels, receptacles, etc.) thatreceive a portion of the exit tubing 112, the saline tubing 116, theplasma tubing 120, and/or the saline and plasma tubing y-connector 280.Upon detecting air in the exit tubing 112, the fluid valve controlsystem 228 may selectively actuate one or more of the fluid controlvalves such as a plasma flow control valve 286 and a saline flow controlvalve 288. In at least one example embodiment, the detection of air viathe air detection sensor 284 may be used to signal an operation stepand/or trigger a step in a control method as described herein.

The plasma flow control valve 286 and/or the saline flow control valve288 may be a solenoid valve, linear actuator, pinch valve, clamp valve,tubing valve, and/or other actuatable valve configured to selectivelyalter (e.g., occlude) a fluid passage associated with a particularportion of the exit tubing 112, the saline tubing 116, or the plasmatubing 120. As shown in FIG. 2D, the plasma flow control valve 286 maybe configured to pinch a portion of the plasma tubing 120 at leastpartially contained in a receiving feature of the saline and plasmavalve housing 276. The saline flow control valve 288 may be configuredto pinch a portion of the saline tubing 116 at least partially containedin a receiving feature of the saline and plasma valve housing 276. Inany event, the plasma flow control valve 286 and the saline flow controlvalve 288 may include an actuatable extendable finger that moves from aretracted, or partially retracted, position to an extended, or partiallyextended, position to pinch the portion of tubing contained in thesaline and plasma valve housing 276. While the plasma flow control valve286 and the saline flow control valve 288 may completely pinch thetubing (e.g., completely restricting fluid flow therethrough), it shouldbe appreciated that the plasma flow control valve 286 and the salineflow control valve 288 may be partially actuated to a position thatpartially restricts fluid flow through a portion of the tubing.

As should be understood, the draw pump 208, the return pump 212, and theAC pump 216 include additional components such as described in Atty.Docket No. 18955-000029-US, entitled “FLUID CONTROL AND BYPASS FEATURESFOR AN APHERESIS SYSTEM”, filed on Mar. 2, 2023 and assigned applicationSer. No. 18/116,527, the entire contents of which are hereinincorporated by reference.

First Example of Soft Cassettes with Integrated Features

FIG. 3A is a partial perspective view of a soft cassette assemblyaccording to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 3A, a detailedperspective view of a disposable soft cassette assembly 300 is shown inaccordance with embodiments of the present disclosure. The soft cassetteassembly 300 may include a baseplate 302 and a cassette access door 304that is attached to the baseplate 302 via at least one hinge 306 and/orcassette access door latch 308. In at least one example embodiment, thecassette access door 304 may be unlocked via actuating a cassette accessdoor latch 308 and pivoting the cassette access door 304 about acassette access door hinge axis 310.

In at least one example embodiment, the soft cassette assembly 300 maybe configured with one or more soft cassette receiving features 312 forat least partially containing and/or locating a soft cassette 314therein. The soft cassette 314 may be a part of the blood componentcollection set described herein. For instance, the soft cassette 314 maybe disposed between the cassette inlet tubing 108A and the loop inlettubing 108B of the extracorporeal tubing circuit (shown in FIG. 5A). Inat least one example embodiment, the soft cassette 314 may provide oneor more features for controlling the flow of blood and/or bloodcomponents from a donor 102 (shown in FIG. 1A) to the apheresis system200 (shown in FIG. 1A), and/or vice versa.

In at least one example embodiment, the soft cassette assembly 300includes an air detection sensor 316, a fluid sensor 318, and one ormore fluid control valves 320A, 320B, 320C configured to control arouting or flow direction of fluid through the soft cassette 314. In atleast one example embodiment, these components may be independentlyembedded in the cassette access door 304, the baseplate 302, and/or aportion of the housing 204 of the apheresis system 200 (shown in FIG.1A). Similar to the guard closure feature 254 described in conjunctionwith FIGS. 2B-2C, the soft cassette assembly 300 may include one or moredoor closure features 328. The door closure features 328 may include,but are not limited to, magnetic catches, protrusions, tabs and slots,and/or other connections. In at least one example embodiment, the doorclosure features 328 may include pressure contact surfaces configured tohold or at least partially position a soft cassette 314 inside the softcassette assembly 300.

In at least one example embodiment, the valves 320A, 320B, 320C mayinclude, but are not limited to, solenoid valves, linear actuators,pinch valves, clamp valves, tubing valves, and/or other actuatable valveconfigured to selectively alter, for example, occlude, a fluid passage(e.g., cross-sectional area, etc.) associated with a particular portionof the soft cassette 314.

In at least one example embodiment, the soft cassette assembly 300 mayinclude a first fluid control valve 320A configured to pinch a portionof the soft cassette 314 adjacent to a cassette inlet tubing 108A. Thesecond fluid control valve 320B may be configured to pinch a portion ofthe soft cassette 314 adjacent to the loop inlet tubing 108B. A drawfluid control valve 320C may be configured to pinch a portion of thesoft cassette 314 along a branch tubing extending from a point adjacentto the cassette inlet tubing 108A to a point adjacent to the loop inlettubing 108B. In at least one example embodiment, each of the valves320A, 320B, 320C may include an actuatable extendable finger that movesfrom a retracted, or partially retracted, position to an extended, orpartially extended, position to pinch the portion of the soft cassette314 contained in the soft cassette assembly 300. While the valves 320A,320B, 320C may completely pinch flow paths in the soft cassette 314(e.g., completely restricting fluid flow therethrough), it should beappreciated that the valves 320A, 320B, 320C may be partially actuatedto a position that partially restricts fluid flow through a portion ofthe soft cassette 314.

In at least one example embodiment, the sensors 316, 318 may be one ormore of an ultrasonic detector, pressure sensor, magnetic positionsensor, and/or the like. In some cases, the fluid sensor 318 may beconfigured to determine whether fluid is present in the soft cassette314 based on a position of a magnet relative to a portion of the softcassette 314. For instance, when the portion of the soft cassette 314 isfilled with a fluid, the magnet may be disposed at a first position froma surface of the soft cassette 314. On the other hand, when the portionof the soft cassette 314 is filled with air, the force from the magnetmay compress the portion of the soft cassette 314 to a second positioncloser to the surface of the soft cassette 314 than the first position.In at least one example embodiment, the detection of air or fluid viathe air detection sensor 316 and the fluid sensor 318, respectively, maybe used to signal an operation step and/or trigger a step in a controlmethod as described herein.

FIG. 3B is a perspective view of a soft cassette of the soft cassetteassembly of FIG. 3A according to at least one example embodiment. FIG.3C is a sectional view of the soft cassette of FIG. 3B taken along line3C-3C of FIG. 3A according to at least one example embodiment. FIG. 3Dis a sectional view of the soft cassette of FIG. 3A taken along line3D-3D of FIG. 3A according to at least one example embodiment.

In at least one example embodiment, the soft cassette 314 may be part ofthe blood component collection set. For instance, the soft cassette 314may be a disposable component used in the blood separation methodsdescribed herein. In at least one example embodiment, the soft cassette314 may be made from a substantially compliant and/or flexible material.The compliant material may be chemically inert and/or be capable ofwithstanding sterilization and cleaning operations, temperatures, and/ortreatments. The soft cassette 314 may be formed from a thermoplasticmaterial. In at least one example embodiment, the soft cassette 314includes polyvinyl chloride (PVC), plasticized-PVC, polyethylene,ethylene with vinyl acetate (EVA), rubber, silicone, thermoplasticelastomer, copolymers thereof, and/or combinations thereof. In at leastone example embodiment, the soft cassette 314 is molded, rotomolded,cast, injection molded, or otherwise formed from one or more of thematerials described above.

In at least one example embodiment, the soft cassette 314 may includeand/or define a first cassette port 340A (shown in FIGS. 3B-3C), asecond cassette port 340B (shown in FIGS. 3B-3C), and a direct flowlumen 350 (shown in FIG. 3C) running between the first and secondcassette ports 340A, 340B. In at least one example embodiment, the firstand/or second cassette ports 340A, 340B may be configured to receiveand/or fluidly couple with one or more tubes of the blood componentcollection set. In at least one example embodiment, the first cassetteport 340A may couple with the cassette inlet tubing 108A and the secondcassette port 340B may couple with the loop inlet tubing 108B. Thesecouplings may be air tight and/or fluid tight. In at least one exampleembodiment, the first and/or second cassette ports 340A, 340B may be orinclude an aperture disposed within the soft cassette 314 that isconfigured to elastically stretch around an end of the tubing (e.g.,cassette inlet tubing 108A, loop inlet tubing 108B, etc.).

In at least one example embodiment, blood supplied by the donor 102(shown in FIG. 1A) may be directed along one or more fluid pathsdisposed within the soft cassette 314. In one embodiment, the blood maybe directed along the direct flow lumen 350 from the first cassette port340A to the second cassette port 340B. In some embodiments, this flowpath may direct the blood through a first or drip chamber 354 of thesoft cassette 314. In some embodiments, blood and/or other fluidsreturned to the donor 102 may be directed along the direct flow lumen350 from the second cassette port 340B to the first cassette port 340A.

In at least one example embodiment, the soft cassette 314 includes afluid flow bypass path provided by a first bypass branch 358 (shown inFIGS. 3B, 3D) having a bypass flow lumen 360 (shown in FIG. 3D) that isfluidly connected to a portion of the direct flow lumen 350 adjacent tothe first cassette port 340A or as part of the first cassette port 340A.In some embodiments, the bypass flow lumen 360 may run from a point ofthe direct flow lumen 350 adjacent to the first cassette port 340A,along the first bypass branch 358, through a second chamber or fluidpressure annulus 362 (shown in FIGS. 3B, 3D) to a second bypass branch364 (shown in FIGS. 3B, 3D), and then reconnect to the direct flow lumen350 at a point adjacent to the second cassette port 340B or as part ofthe second cassette port 340B. As the name suggests, the bypass flowlumen 364 provides a flow path within the soft cassette 314 thatbypasses the drip chamber 354.

In at least one example embodiment, controlling the flow path, ordirecting fluid, within the soft cassette 314 may include actuating thefluid control valves 320A, 320B, 320C (shown in FIG. 3A) of the softcassette assembly 300 to interact with various compliant regions 370A,370B, 370C (shown in FIG. 3B) blocking and/or opening portions of thedirect flow lumen 350 and/or bypass flow lumen 360. The first compliantregion 370A provides a pinch valve area at a point along the direct flowlumen 350 between the first cassette port 340A and the drip chamber 354near a first cassette end 372 of the soft cassette 314. When the firstfluid control valve 320A is actuated, the valve 320A may pinch thedirect flow lumen 350 closed at this first compliant region 370A,restricting or completely preventing the flow of fluid at this point inthe soft cassette 314. The second compliant region 370B provides a pinchvalve area at a point along the direct flow lumen 370 between the secondcassette port 340B and the drip chamber 354 near a second cassette end374 (e.g., opposite the first cassette end 372). When the second fluidcontrol valve 320B is actuated, the valve 320B may pinch the direct flowlumen 370 closed at this second compliant region 370B, restricting orcompletely preventing the flow of fluid at this point in the softcassette 314. As can be appreciated, the third compliant region 370Cdisposed along the first bypass branch 358 adjacent to the fluidpressure annulus 362 may provide a pinch valve area at a point along thebypass flow lumen 360. When the draw fluid control valve 320C isactuated, the valve 320C may pinch the bypass flow lumen 360 closed atthis third compliant region 370C, restricting or completely preventingthe flow of fluid through the bypass flow lumen 360.

In at least one example embodiment, as shown in the elevation sectionview of FIG. 3C, taken through a plane running through the direct flowlumen 350 and drip chamber 354, the direct flow lumen 350 runs from thefirst cassette port 340A through an inner chamber volume 376 of the dripchamber 354 to the second cassette port 340B. The direct flow lumen 350may be formed as a fluid passage running inside a first tubing section378, the inner chamber volume 376, and a second tubing section 379 ofthe soft cassette 314.

In at least one example embodiment, the bypass path of the soft cassette314 may include the fluid pressure annulus 362 through which fluid canflow from the first bypass branch 358 to the second bypass branch 364,and/or vice versa. In at least one example embodiment, a pressurediaphragm 380 (shown in FIG. 3D) may be formed in the material of thesoft cassette 314 an area within, or adjacent to, the fluid pressureannulus 362. The fluid pressure annulus 362 and pressure diaphragm 380are illustrated in the elevation section view of FIG. 3D taken through aplane running through the fluid pressure annulus 362 and a portion ofthe first and second bypass branches 358, 364.

In at least one example embodiment, the pressure diaphragm 380 mayprovide a contact, or measurement, surface for the fluid sensor 318 todetect whether the fluid pressure annulus 362 and/or the bypass flowlumen 360 includes an amount of fluid, air, and/or combinations thereof.As provided above, as fluid fills a portion of the fluid pressureannulus 362, the fluid may provide greater resistance to movement thanwhen the fluid pressure annulus 362 is filled with air. This differencein resistance may be measured via the fluid sensor 316 to determine,among other things, an amount and/or type of fluid (e.g., air, blood,etc.) in the bypass flow lumen 360 and/or the fluid pressure annulus362.

Example Centrifuge Assembly

FIG. 4A is a perspective view of an example centrifuge assembly 400 foruse in the apheresis system 200 in accordance with at least one exampleembodiment of the present disclosure. The centrifuge assembly 400 may bedisposed in an interior space of the apheresis system 200. The interiorspace may be at least partially enclosed with one or more elements ofthe housing 204 and/or centrifuge chamber. Access to the interior spaceand the centrifuge assembly 400 may be provided via the access panel 224disposed at the front 202 of the apheresis system 200. For example, inFIG. 4A, the access panel 224 is shown in an open position, opened alongthe hinged axis 226. The hinged axis 226 may correspond to a door hinge,continuous hinge, cleanroom hinge, and/or other panel hinges.

The centrifuge assembly 400 may be operatively mounted inside theapheresis system 200 such that the assembly 400 is capable of rotatingrelative to the housing 204 and/or other elements of the apheresissystem 200. The centrifuge assembly 400 may be loaded with one or moreportions of the blood component collection set (for example, the bloodcomponent collection set 500 illustrated in FIGS. 5A-5H) by routingtubing (e.g., the inlet tubing 108B and the exit tubing 112, etc.) intothe interior space of the apheresis system 200 (e.g., via the opening220 shown in FIG. 2A), connecting a portion of the blood componentcollection loop 520 to the fixed loop connection 402 and inserting theblood component collection bladder 536 into a filler 460. The fixed loopconnection 402 maintains the inlet tubing 108B and the exit tubing 112in a fixed position and may prevent twisting of the tubing 108B, 112outside of the apheresis system 200. In at least one example embodiment,the blood component collection loop 520 may be interconnected to thefixed loop connection 402 via one or more keyed features or positivelocation features.

For illustrative purposes, FIGS. 4B-4C show the centrifuge assembly 400separated from the apheresis system 200. The centrifuge assembly 400 mayinclude a centrifuge split-housing 404 comprising a lower housing 404Apivotally connected to an upper housing 404B. The upper housing 404B mayopen to provide access for loading a blood component collection bladder(for example, the blood component collection set 500 illustrated inFIGS. 5A-5H) into the centrifuge assembly 400. In at least one exampleembodiment, the upper housing 404B may pivot about the split-housingpivot axis 406 (e.g., configured as a hinge, pin, fastener, shoulderbolt, etc.).

The different halves (e.g., the lower housing 404A and upper housing404B) of the centrifuge split-housing 404 may be configured to lockand/or unlock together. Unlocking the upper housing 404B from the lowerhousing 404A may provide access to an interior of the centrifugeassembly 400. This selective locking may be achieved by rotating theupper housing 404B relative to the lower housing 404A about thecentrifuge rotation axis 430. Although the centrifuge split-housing 404is shown in FIGS. 4B-4C in an unlocked state, it should be appreciatedthat the upper housing 404B can be rotated (e.g., in a counterclockwisedirection) about the centrifuge rotation axis 430 to engage one or morelocking tabs 428 or elements of the upper housing 404B with lockingslots 432 disposed in the lower housing 404A (as shown, for example, inFIG. 4C). When in the unlocked position, the upper housing 404B may beopened, or pivoted, about the split-housing pivot axis 406 to load thecentrifuge assembly 400 with a blood component collection loop 520and/or a blood component collection bladder 536. When in the lockedposition, the upper housing 404B is rotationally locked relative to thelower housing 404A, and the two halves of the centrifuge split-housing404 may spin together, locked in unison, during a centrifuge or bloodseparation operation.

The centrifuge assembly 400 may include at least one clockwise rotationstop 408A, counterclockwise rotation stop 408B, upper housing clockwiserotation flag 410A, and/or upper housing counterclockwise rotation flag410B. In at least one example embodiment, the rotation stops 408A, 408Bmay be rotationally fixed relative to the centrifuge rotation axis 430of the lower housing 404A. The rotation flags 410A, 410B may beattached, or formed in, the upper housing 404B and configured to contactrespective rotation stops 408A, 408B to prevent over-rotation of theupper housing 404B relative to the lower housing 404A when lockingand/or unlocking the two halves of the centrifuge split-housing 404together. For instance, upon rotating the upper housing 404B in aclockwise, or unlocking, direction about the centrifuge rotation axis430, a portion of the upper housing clockwise rotation flag 410A maycontact the clockwise rotation stop 408A preventing further rotation inthe clockwise direction. Additionally or alternatively, upon rotatingthe upper housing 404B in a counterclockwise, or locking, directionabout the centrifuge rotation axis 430, a portion of the upper housingcounterclockwise rotation flag 410B may contact the counterclockwiserotation stop 408B preventing further rotation in the counterclockwisedirection. In at least one example embodiment, the centrifugesplit-housing 404 may include one or more locking elements configured tomaintain the halves of the centrifuge split-housing 404 in a lockedstate, while the locking elements are engaged.

In at least one example embodiment, the centrifuge split-housing 404 mayinclude a pull ring 412 attached to a portion of the upper housing 404Bto pivot the upper housing 404B relative to the lower housing 404A aboutthe split-housing pivot axis 406. The pull ring 412 may provide anaperture, through which a user may insert a finger and apply a pullforce to a rotationally unlocked upper housing 404B.

The centrifuge assembly 400 may include a rotor and motor assembly 414that is controlled and/or powered via electrically interconnectedelectrical cabling 420. The electrical cabling 420 may include aconnector that attaches to a controller, processor, and/or power supply.This electrical cabling 420 may convey power and/or data signals betweenthe rotor and motor assembly 414 and one or more controllers/processorsof the apheresis system 200. The rotor and motor assembly 414 may beconfigured as an electric motor and/or portions of an electric motorthat rotate the complete centrifuge assembly 400 relative to theapheresis system 200 (e.g., relative to a portion of the housing 204and/or base of the apheresis system 200). In other words, the rotor andmotor assembly 414 may include one or more components that cause thecentrifuge assembly 400 (e.g., both halves of the centrifugesplit-housing 404 together) to rotate inside the apheresis system 200.

As described herein, the centrifuge assembly 400 may include one or morefeatures to guide, contain, and/or position elements of the bloodcomponent collection set relative to the centrifuge split-housing 404.For example, in FIG. 4B, the blood component collection loop 520 isshown captured in an operational position in a loop rotational positionguide 424 comprising a loop capture arm 416. The loop rotationalposition guide 424 may include a number of bearings 417, and/or bearingsurfaces, arranged to at least partially support the blood componentcollection loop 520 in an operational position. In the operationalposition, the blood component collection loop 520 may twist along itslength within the support provided by the bearings 417 of the looprotational position guide 424. For example, the blood componentcollection loop 520 may be fixedly attached at one end to the fixed loopconnection 402 of the apheresis system 200 while the other end of theblood component collection loop 520 may be attached to a filler 460(e.g., the inner rotating component of the centrifuge assembly 400. Asthe centrifuge assembly 400 spins during a centrifuge operation, thetwisting of the blood component collection loop 520 between the fixedloop connection 402 and the connection at the filler 460 may cause thefiller 460 to rotate relative to the centrifuge split-housing 404 of thecentrifuge assembly 400. In at least one example embodiment, the lowinertia of the filler 460 coupled with the twisting of the bloodcomponent collection loop 520 as the centrifuge assembly 400 rotates inthe apheresis system 200, may cause the filler 460 to rotate at twotimes the angular velocity of the centrifuge split-housing 404 in thesame direction of spin. In this example, when the centrifugesplit-housing 404 spins in a counterclockwise direction about thecentrifuge rotation axis 430 at a first angular velocity, 1ω, the filler460 may spin inside the centrifuge split-housing 404 in thecounterclockwise direction at a second angular velocity, 2ω (e.g.,substantially two times the first angular velocity, etc.).

The centrifuge assembly 400 may include one or more balancing features,elements, and/or structures disposed about the centrifuge rotation axis430 of the centrifuge assembly 400. These balancing features may providean axially balanced centrifuge assembly 400, such that when spun on thecentrifuge rotation axis 430, the centrifuge assembly 400 may impartsubstantially no vibration to the apheresis system 200. In at least oneexample embodiment, a centrifuge balance weight 418 may be attached to aportion of the centrifuge split-housing 404 (e.g., the lower housing404A and/or the upper housing 404B, etc.). This centrifuge balanceweight 418 may be custom tuned for the centrifuge assembly 400 and assuch may be selectively attached and removed from the centrifugeassembly 400. The tuning of the centrifuge balance weight 418 may becalculated and/or empirically derived to produce a completely balancedcentrifuge assembly 400, especially when loaded with one or moreelements of the blood component collection set.

FIG. 4C shows a rear perspective view of the centrifuge assembly 400 inaccordance with at least one example embodiment of the presentdisclosure. A portion of the filler 460 is visible through an aperturein the upper housing 404B. The blood component collection loop 520 isshown in an initial loop loading position 520A, where a first end isinterconnected with the filler 460 and a second end is fixedly attachedto the fixed loop connection 402 (not shown). The blood componentcollection loop 520 is shown passing through a loop access clearance 436in the centrifuge split-housing 404. When the blood component collectionloop 520 is loaded in the loop loading position 520A a portion of theblood component collection loop 520 may be partially contained, held,and/or supported by a loop containment bracket 426. The loop containmentbracket 426 may include one or more bearings 417 (e.g., roller bearings,ball bearings, needle bearings, etc., and/or assemblies thereof, etc.),or bearing surfaces, arranged to at least partially support the bloodcomponent collection loop 520 as it twists relative to the centrifugeassembly 400. In at least one example embodiment, the blood componentcollection loop 520 may rotate about an axis running along the length ofthe flexible loop 524 (e.g., in an installed or mounted condition and/orstate, etc.) allowing for relative rotational motion of the flexibleloop 524 to the loop rotational position guide 424. For instance, theloop does not “twist up” but actually rotates, or rolls, relative to theloop rotational position guide 424 (e.g., support structure) in betweenone or more bearings 417. This rotation or torsion, without binding ortwisting up the flexible loop 524, may be referred to herein as a twist.The twist allows the flexible loop 524 to transmit rotational force tothe filler 460 without a substantial reduction in the inside diameter ofthe lumen of the flexible loop 524. In some cases, there is no reductionin the inside diameter of the lumen of the flexible loop 524.

As described above, when the upper housing 404B is rotated from therotationally unlocked position shown in FIGS. 4B-4C, to a rotationallylocked position, the locking tab 428 of the upper housing 404B mayengage with the locking slot 432 in the lower housing 404A. Additionallyor alternatively, when moved into the rotationally locked position, theloop containment bracket 426 may rotate, along with the blood componentcollection loop 520 and the upper housing 404B, to a position in-linewith the loop rotational position guide 424 along the loop engagedposition 520B. In at least one example embodiment, the loop capture arm416 may guide the blood component collection loop 520 into the bearings417 and/or bearing surfaces of the loop rotational position guide 424 asthe upper housing 404B and the blood component collection loop 520rotate into the loop engaged position 520B. Further details regardingthe loading of the blood component collection loop 520 are described inconjunction with FIGS. 6A-7B below.

FIGS. 4D-4F show various schematic section views taken through thecenter of the centrifuge assembly 400 (e.g., bisecting the centrifugeassembly 400 through the centrifuge rotation axis 430, etc.). Asdescribed above, the centrifuge assembly 400 may include a lower housing404A that is pivotally attached to an upper housing 404B by asplit-housing pivot axis 406, or hinge. The upper housing 404B may beattached to an upper housing adapter 440 that is rotationallyinterconnected to the upper housing bushing block 442 attached to thepull ring 412. In at least one example embodiment, a bearing 417,bushing, or bearing surface may be disposed between the upper housingadapter 440 and the upper housing bushing block 442 allowing the upperhousing 404B to rotate along centrifuge rotation axis 430 from a lockedposition into an unlocked position, and vice versa. The pull ring 412may be rotationally fixed about centrifuge rotation axis 430 relative tothe lower housing 404A. In at least one example embodiment, the upperhousing adapter 440 and the upper housing 404B may be formed from anintegral structure.

The filler 460 may be fixedly attached to a filler mandrel 434 that isconfigured to rotate relative to the upper housing 404B about centrifugerotation axis 430. In at least one example embodiment, the fillermandrel 434 may be formed from a portion of the filler 460. In anyevent, one or more mandrel support bearings 444 may be disposed betweenthe filler mandrel 434 and the upper housing adapter 440 allowing thefiller 460 to rotate inside the centrifuge split-housing 404 andcentrifuge assembly 400 about the centrifuge rotation axis 430. In atleast one example embodiment, the filler mandrel 434 may be retained inan operative position via at least one retaining nut 438. The filler 460and filler mandrel 434 may spin together relative to the centrifugesplit-housing 404

FIG. 4D shows a schematic section view of the centrifuge assembly 400 ina closed state (e.g., prior to loading the blood component collectionloop 520). Upon unlocking the upper housing 404B relative to the lowerhousing 404A, an operator may pull on the pull ring 412 to pivot theentire upper housing 404B and filler 460 about the split-housing pivotaxis 406. In at least one example embodiment, the upper housing 404B andthe filler 460 may be partially opened by pivoting the components aboutthe split-housing pivot axis 406 in an opening direction 446. Forexample, as illustrated, in FIG. 4E, where the centrifuge assembly 400is shown in a partially opened state, the upper housing 404B and filler460 are rotated out of axis from the lower housing rotation axis 430A.In this position, the filler 460 may be allowed to rotate about thefiller rotation axis 430B. When the lower housing 404A and upper housing404B are in a closed state, the lower housing rotation axis 430A and thefiller rotation axis 430B align (coincidentally, or substantiallycoincidentally) to form the centrifuge rotation axis 430.

Continuing to rotate the upper housing 404B and the filler 460 about they-axis of the split-housing pivot axis 406 in the opening direction 446(e.g., by continuing to pull the pull ring 412) may cause the upperhousing 404B and the filler 460 to pivot substantially 180 degrees fromthe closed position shown in FIG. 4D. As shown in FIG. 4F, thecentrifuge assembly 400 is in an open, or loading, state. In thisposition, the upper housing 404B and the filler 460 may be pivotedoutside of the interior space of the apheresis system 200. For example,at least a portion of the upper housing 404B and/or the filler 460 maybe positioned through an open space of the opened access panel 224. Inthis position, a loading access area 450 may be provided to the loopconnection area 454 of the filler 460. As can be appreciated, orientingthe upper housing 404B in the open position provides easy access to theinterior of the upper housing 404B and the filler 460. Among otherthings, this arrangement may provide ample clearance for an operator toattach the blood component collection loop 520 to the filler 460 at theloop connection area 454.

Referring to FIG. 4G, a perspective view of a filler 460 for thecentrifuge assembly 400 is shown in accordance with at least one exampleembodiment of the present disclosure. In at least one exampleembodiment, the filler 460 may be made from a lightweight material suchas plastic, carbon fiber, aluminum, etc. In at least one exampleembodiment, the filler 460 may be three-dimensionally (3D) printed via a3D printing machine. For instance, the filler 460 may be produced via anadditive manufacturing technique or system such as fused depositionmodeling (FDM), selective laser sintering (SLS), stereolithography(SLA), and/or other additive manufacturing machines. Among other things,these additive rapid prototyping manufacturing techniques can allow formore complex geometries of the filler 460 that may not be possiblethrough the use of conventional machining or manufacturing processes. Inat least one example embodiment, the material of the filler 460 may beselected based on a desired mass of the filler 460, the desired physicalstrength of the manufactured filler 460, and/or suitable material foruse in manufacturing.

The filler 460 may include a loop connection area 454 disposedsubstantially at the center of the filler 460. The loop connection area454 may include one or more keying, or positive location, features for aportion of the blood component collection loop 520 to engage. As shownin FIG. 4G, the loop connection area 454 includes a first positivelocation feature 478 disposed along a portion of the center axis of thefiller 460. The first positive location feature 478 may be a keyway,groove, slot, or other feature for engaging with a mating featuredisposed on the blood component collection loop 520. In at least oneexample embodiment, the filler 460 may include a second positivelocation feature 480 in the loop connection area 454. The locationfeatures 478, 480 may prevent rotation of the blood component collectionloop 520 at the loop connection area 454 and/or prevent the bloodcomponent collection loop 520 from disengaging from the loop connectionarea 454 of the filler 460.

In at least one example embodiment, the filler 460 may include acollection insert channel 466 configured to receive, and at leastpartially contain, a blood component collection bladder of the bloodcomponent collection set and, more specifically, the blood componentcollection loop 520. The collection insert channel 466 may be configuredas a groove, slot, extending outwardly, in a substantially spiralfashion, from a center of the filler 460. In at least one exampleembodiment, the collection insert channel 466 may follow a substantiallyspiral shaped path that may include a first spiral path portionextending outwardly from the center of the filler 460 to a substantiallyconstant radius (e.g., about the center of the filler 460) along alength of the collection insert channel 466 periphery. In any event, thepath may be referred to herein as a spiral path or a substantiallyspiral path. The collection insert channel 466 may start at a channelentrance 468 adjacent to the center of the filler body 464 and terminateat a channel end 472 adjacent at a point furthest from the center of thefiller body 464. As shown in FIGS. 4G-4I, the collection insert channel466 may extend along a substantially spiral path 490 running from apoint adjacent to the filler rotation axis 430B to the channel end 472.The substantially spiral path 490 may include a channel path jog 476 ata point near, or adjacent to, the channel end 472. This channel path jog476 may extend the distance of the collection insert channel 466 fromthe center of the filler body 464 thereby increasing the centripetal andcentrifugal forces at the channel end 472 of the collection insertchannel 466. In at least one example embodiment, this channel path jog476 may correspond to a critical inlet and exit port at a radial maximumwithin a blood component collection bladder 536 that is inserted ordisposed, at least partially, within the collection insert channel 466of the filler 460. In at least one example embodiment, the filler 460may include one or more filler balance protrusions 482 disposed on, in,or about a portion of the filler body 464. These filler balanceprotrusions 482 may provide an axially balanced (e.g., about the fillerrotation axis 430B) filler 460, especially when the collection insertchannel 466 includes a blood component collection bladder and fluid(e.g., blood, blood components, etc.).

FIG. 4I is a schematic plan view of a substantially spiral-shapedreceiving channel, or collection insert channel 466, for a filler 460 inaccordance with at least one example embodiment of the presentdisclosure. The schematic plan view shows a first distance, R1, of thecollection insert channel 466 from a center of the filler body 464(e.g., adjacent to the filler rotation axis 430B, etc.) at a first pointalong the substantially spiral path 490 and a second distance, R2, ofthe collection insert channel 466 from the center of the filler body 464past a point adjacent to the channel path jog 476. As illustrated inFIG. 4I, the second distance, R2, is further from the center of thefiller body 464 than the first distance, R1. This increase in distancemay provide higher centripetal and centrifugal forces in the channel ata point near, or at, the channel end 472 than at any other point alongthe substantially spiral path 490. In at least one example embodiment,the end of the blood collection bladder may substantially coincide withthe channel end 472, providing the greatest blood separation forces atthe end of the bladder.

FIGS. 4J-4L show various elevation sections of the filler 460 and, morespecifically of, the collection insert channel 466 and filler insertchamber 492 disposed inside the filler body 464. In at least one exampleembodiment, the collection insert channel 466 may include across-section, or shape, that substantially follows the substantiallyspiral path 490 in the filler body 464. The collection insert channel466 may include an insert groove configured to receive a substantiallyflat, or unfilled, blood component collection bladder. The bloodcomponent collection bladder may be inserted into the collection insertchannel 466 and a filler insert chamber 492 formed in the filler body464 along the substantially spiral path 490. The filler insert chamber492 may be defined by one or more sidewalls 494, 496 forming a cavitythat follows the substantially spiral path 490. As shown in FIG. 4K, thefiller insert chamber 492 includes an inner chamber wall 494 separated adistance from at least one outer chamber wall 496. The filler insertchamber 492 may be formed in the filler 460 by 3D printing the filler460 and/or by some other metal or plastic forming operation, oroperations (e.g., casting, molding, forming, etc.). In at least oneexample embodiment, the filler insert chamber 492 may include one ormore insert guide features 498. These insert guide features 498 may beconfigured to guide, locate, and/or seat a blood component collectionbladder inside the filler insert chamber 492 of the filler 460. Althoughshown as a chamfered, or lead-in, feature of the filler insert chamber492, the insert guide feature 498 may include one or more radius,chamfer, slope, taper, draft angle, receptacle, groove, and/or othershaped material configured to direct and/or orient a portion of aninserted blood component collection bladder.

FIG. 4L shows different states of fluid collection bladders (e.g., bloodcomponent collection bladders, etc.) disposed inside the collectioninsert channel 466 and the filler insert chamber 492 of the filler 460.As described above, a blood component collection bladder may be insertedinto the collection insert channel 466 in a substantially flat, orunfilled, state, S1. In the substantially flat state, S1, the bloodcomponent collection bladder may be sized to enter the upper opening ofthe collection insert channel 466 and be maintained in a pre-fillcondition inside the filler insert chamber 492. When the filler 460begins to spin and separate blood components from blood provided by adonor 102, the blood component collection bladder may expand from thesubstantially flat first state, S1, to an expanded, or filled, state,S2. In at least one example embodiment, the blood component collectionbladder may expand with blood and/or blood components until the walls ofthe blood component collection bladder contact the walls 494, 496 of thefiller insert chamber 492. In at least one example embodiment, the shapeof the filler insert chamber 492 may be designed to optimize the amountof fluid (e.g., maximize the volume of fluid while minimizing the amountof material for the filler 460) capable of being collected and/orseparated in the filler insert chamber 492.

Example Blood Component Collection Set

FIGS. 5A-5H illustrate a blood component collection set 500 prepared inaccordance with at least one example embodiment of the presentdisclosure. The blood component collection set 500 includes variousconnections that include, for example, tubes and connectors. Forexample, as illustrated, the blood component collection set 500 mayinclude one or more tubes, such as the cassette inlet tubing 108A, theloop inlet tubing 108B, the anticoagulant tubing 110, the loop exittubing 112, the saline tubing 116, and/or the plasma tubing 120, andalso one or more connectors, such as the tubing connector 106 and/or thesaline and plasma tubing y-connector 280. The blood component collectionset 500 may also include one or more other connectors, such as a firsttubing fitting 504, a second tubing fitting 508, a bag fitting 512, asystem static loop connector 528, and/or a filler loop connector 532.The various connections may fluidly connect the soft cassette 340 andthe blood component collection loop 520.

The one or more tubes, including the cassette inlet tubing 108A, theloop inlet tubing 108B, the anticoagulant tubing 110, the loop exittubing 112, the saline tubing 116, and/or the plasma tubing 120(collectively referred to as “the tubing”), each have a central lumenconfigured to convey fluid therethrough. The tubing may include one ormore polymeric materials, including, for example, polyvinyl chloride(PVC), plasticized-polyvinyl chloride, polyethylene, ethylene vinylacetate (EVA), rubbers, copolymers and combinations thereof.

The one or more connectors, including the tubing connector 106, thesaline and plasma tubing y-connector 280, the first tubing fittings 504,the second tubing fitting 508, the bag fitting 512, the system staticloop connector 528, and/or the filler loop connector 532 (collectivelyreferred to as “the connectors”), may be each configured to fluidlyinterconnect the tubing and/or to fluidly interconnect the tubing andother medical accessories and/or to fluidly interconnect the tubing andneedles or spikes. For example, the connectors may insert into thecentral lumen of the respective tube and/or attach to an outside of therespective tube and/or the bag fitting 512 may be configured to beinserted into a receiving bag, like the saline bag 118. In at least oneexample embodiment, the connectors may include various fittings,including, for example, Luer fittings, twist-to-connect fittings, and/orother small-bore couplings, to provide universal and/or reliableinterconnections for establishing fluid connections.

As illustrated, the blood component collection loop 520 may include aflexible loop 524 disposed between the system static loop connector 528and the filler loop connector 532. The static loop connector 528 may beattached to the flexible loop 524 and/or a blood component collectionbladder 536, as further discussed below, by a mechanical lock, which canbe formed with a photo curable adhesive. The flexible loop 524 may beconfigured as a hollow flexible tube configured to receive and/orcontain at least a portion of the loop inlet tubing 108B and the loopexit tubing 112. In at least one example embodiment, the flexible loop524 may include a thermoplastic elastomer having enhanced flexibilityfor transmitting twist from a first end of the flexible loop 524 towardsand to a second distal end. Such thermoplastic elastomers may providethe flexibility of rubber while maintaining the strength and torquecharacteristics of plastics. Examples of the thermoplastic elastomer mayinclude, for example, copolyester, DUPONT™ HYTREI® thermoplasticelastomers, EASTMAN NEOSTAR™ elastomers, CELANESE RITEFLEX® elastomers,TOYOBO PELPRENE®, and/or other similar brand elastomers offering highflexibility and strength characteristics.

In at least one example embodiment, the blood component collection loop520 may include a blood component collection bladder 536. The bloodcomponent collection bladder 536 may have a first or bladder loop end540A and a second or bladder free end 540B. The blood componentcollection bladder 536 may include a first collection flow chamber 544extending between the bladder loop end 540A and the bladder free end540B and connected to the flexible loop 524 via the filler loopconnector 532. For example, in at least one example embodiment, fluidmay flow between the loop inlet tubing 108B and the first collectionflow chamber 544 via the flowpath defined by the flexible loop 524, thesystem static loop connector 528, and the filler loop connector 532. Thebladder free end 540B of the first collection flow chamber 544 mayinclude a flow chamber transition 548 and fluid flowing from the bladderloop end 540A to the bladder free end 540B via first collection flowchamber 544 may enter a second collection flow chamber 552 via the flowchamber transition 548. The second collection flow chamber 552 may beconnected to the flexible loop 524 via the filler loop connector 532.For example, in at least one example embodiment, fluid may flow betweenthe loop exit tubing 112 and the second collection flow chamber 552 viaa flowpath defined by the flexible loop 524, the system static loopconnector 528, and the filler loop connector 532.

In at least one example embodiment, as illustrated in FIG. 5B, theflexible loop 524 may include a first distinct pathway 509 that isconfigured to receive the loop inlet tubing 108B and a second distinctpathway 510 that is configured to receive the loop exit tubing 112. Forexample, in at least some example embodiment, at least a portion of theloop inlet tubing 108B may be held within the first pathway 509 of theflexible loop 524 and connected with the first collection flow chamber544 at the bladder loop end 540A via the filler loop connector 532.Additionally, or alternatively, at least a portion of the loop exittubing 112 may be held within the second pathway 510 of the flexibleloop 524 and connect with the second collection flow chamber 552 at thebladder loop end 540A via the filler loop connector 532. In this manner,fluid enters the blood component bladder 536 via the first collectionflow chamber 544, where the fluid can be separated (e.g., into one ormore blood components) and conveyed along the second collection flowchamber 552 to the loop exit tubing 112 held within the second pathway510 of the flexible loop 524.

As illustrated, the first collection flow chamber 544 may be separatedfrom the second collection flow chamber 552 via a flow chamber separator542. In at least one example embodiment, the flow chamber separator 542may be a sealed portion (e.g., heat sealed) of the blood componentcollection bladder 536. For example, in at least one example embodiment,the blood component collection bladder 536 may include, and may beprepared from, one or more overlapping and sealed material layers. Thematerial layers may include one or more polymeric materials. Forexample, in at least one example embodiment, the material layers mayinclude polyvinyl chloride (PVC), plasticized-polyvinyl chloride,polyethylene, ethylene vinyl acetate (EVA), thermoplastics,thermoplastic elastomer, copolymers and combinations thereof.

The material layers may be shaped (e.g., cut or otherwise shaped, etc.)and sealed along one or more edges to form the blood componentcollection bladder 536. As illustrated in FIGS. 5C and 5D, the flowchamber separator 542 may be formed in the blood component collectionbladder 536 by sealing the one or more material layers to one or moreother material layers, and/or one or more first portions of a singlematerial layer to one or more second portions of the single materiallayer, along one or more preselected path. For example, as illustratedin FIG. 5D, which shows the blood component collection bladder 536 priorto the sealing, the flow chamber separator 542 may be formed as a sealedregion of material by joining a bladder first side material 536A to abladder second side material 536B. The bladder first side material 536Aand the bladder second side material 536B may also be sealed at one ormore ends 554A, 554B to form a top and bottom of the blood componentcollection bladder 536. By way of comparison, FIG. 5C shows the bloodcomponent collection bladder 536 after the sealing. As illustrated inFIGS. 5A and 5B, the seal defining the flow chamber separator 542 doesnot extend the entire length of the blood component collection bladder536 and thereby defines the flow chamber transition 548 such that fluidcan pass between the first collection flow chamber 544 and the secondcollection flow chamber 552.

Once formed, the width of the bladder (WB) may correspond to the widthof the first collection flow chamber 544 and/or the second collectionflow chamber 552 in an unexpanded state (S1) (see, FIG. 4L). Duringoperation, as fluid fills at least a portion of the blood componentcollection bladder 536, the width of the bladder (WB) may increase indimension from the resting dimension illustrated in FIG. 5C. Forexample, in at least one example embodiment, the width of the bladder(WB) may increase substantially to the size of the filler insert chamber492 of the filler 460. In at least one example embodiment, the sealed towelded portions of the blood component collection bladder 536 may besupported in the filler 460. For example, as illustrated in FIGS. 5G and5H, a top of the filler 460 may support the top two seals 554A, 542 andthe bottom of the filler 460 may support the bottom seal 554B.

In at least one example embodiment, the blood component collection loop520 may include one or more location features (also referred to as keyfeatures) 530A, 530B that are configured to help positively locateportions of the blood component collection loop 520 relative to theapheresis system 200, and more specifically, the filler 460 of thecentrifuge assembly 400. For example, as illustrated, the bloodcomponent collection loop 520 may include a first connector locationfeature 530A on or near the system static loop connector 528 and/or asecond connector location feature 530B on or near the filler loopconnector 532. The location features 530A, 530B may be configured as akey, a tab, and/or other material protrusion that extends from therespective connector 528, 532. In at least one example embodiment, thesecond connector location feature 530B may include features thatinterconnect (e.g., mate) with the first positive location feature 478and/or the second positive location feature 480 of the loop connectionarea 454 in the filler 460.

FIGS. 5E-5H are various perspective views of the blood componentcollection loop 520 in a flexed state and also illustrate the flexedblood component collection bladder 536 of the blood component collectionloop 520 as inserted into the filler 460 of the centrifuge assembly 400.The various components of the blood component collection loop 520 may beflexible and/or capable of being formed or shaped by the application offorce. In at least one example embodiment, this flexibility may beelastic such that forming the various parts of the blood componentcollection loop 520 does not permanently deform the components.

FIG. 5E illustrates the blood component collection loop 520 in a flexedstate. For example, in FIG. 5E, the flexible loop 524 is shownelastically bent along its length and the blood component collectionbladder 536 is shown following a number of bends or curves along itslength. The flexible loop 524 nonetheless provides fluids to the bloodcomponent collection bladder 536, for example, via the loop inlet tubing108B, and/or takes fluids away from the blood component collectionbladder 536, for example, via the loop exit tubing 112, while one ormore of the various components of the blood component collection loop520 are in a flexed state.

In at least one example embodiment, the blood component collection loop520 may be pre-formed, for example, as illustrated in FIG. 5F, to fitwithin the collection insert channel 466 of the filler 460 of thecentrifuge assembly 400. The pre-forming may include twisting the bloodcomponent collection bladder 536 of the blood component collection loop520 so as to match the substantially spiral path 490 of the collectioninsert channel 466. Once pre-formed, the features of the blood componentcollection loop 520 may be aligned with one or more features of thefiller 460, as illustrated in FIG. 5G. For example, in one at least oneexample embodiment, the filler loop connector 532 of the blood componentcollection loop 520 may be aligned with the loop connection area 454 ofthe filler 460 such that the second connector location feature 530B isaligned to engage with the first positive location feature 478.Additionally, or alternatively, the blood component collection bladder536 may be shaped, or formed (e.g., manually or automatically), to matchthe substantially spiral path 490 of the collection insert channel 466in the filler 460. In at least one example embodiment, this shaping orforming may include aligning the bladder free end 540B of the bloodcomponent collection bladder 536 with the channel end 472 of thecollection insert channel 466 in the filler 460. When the components aregenerally aligned with one another, the blood component collection loop520 may be moved in a direction toward the collection insert channel 466and the loop connection area 454, as shown in FIG. 5G. In at least oneexample embodiment, when the filler loop connector 532 is moved towardand into the loop connection area 454 of the filler 460, the firstpositive location feature 478 may interconnect and/or retain the secondconnector location feature 530B of the filler loop connector 532 of theblood component collection loop 520. This interconnection may preventthe filler loop connector 532 from rotating relative to the filler 460.In at least one example embodiment, the interconnection may maintain thefiller loop connector 532 of the blood component collection loop 520inside the loop connection area 454 of the filler 460. FIG. 5Hillustrates the blood component collection loop 520 as loaded in thefiller 460. The system static loop connector 528 and the filler loopconnector 532 can work together to transfer torque as applied to theflexible loop 524 to the blood component collection bladder 536 and thefiller 460.

In at least one example embodiment, fluid (e.g., blood and/or bloodcomponents, etc.) in the blood component collection bladder 536contained in the filler insert chamber 492 of the filler 460 may travelin a direction toward the bladder free end 540B along the firstcollection flow chamber 544 around an end of the flow chamber separator542 (e.g., following blood component movement direction 546) and intothe second collection flow chamber 552. In this example, bloodcomponents (e.g., plasma, etc.) may be forced back along thesubstantially spiral path 490 toward the center of the filler body 464along the second collection flow chamber 552 and through the loop exittubing 112 (e.g., to a plasma collection bottle 122).

Example Centrifuge Assembly in Loop-Loading State

FIGS. 6A-6C are schematic section views of a centrifuge assembly 400 invarious loop-loading states in accordance with at least one exampleembodiment of the present disclosure. The centrifuge assembly 400 asillustrated in FIGS. 6A-6C may correspond to the centrifuge assembly 400described above and especially in conjunction with FIGS. 4D-4F. Inparticular, FIG. 6A shows a schematic section view of a firstloop-loading state, FIG. 6B shows a schematic section view of a secondloop-loading state, and FIG. 6C shows a schematic section view of asecond loop-loading state for the centrifuge assembly 400.

In FIG. 6A, the centrifuge assembly 400 is shown in an open,loop-loading, position where the upper housing 404B has been pivoted 180degrees from a closed, or operational, position. This open position maycorrespond to the position of the centrifuge assembly 400 shown in FIG.4F. However, in FIG. 6A, a blood component collection loop 520 has beeninserted into the filler 460 and the filler loop connector 532 isinterconnected to the loop connection area 454 of the filler body 464.The other end of the blood component collection loop 520 is connected tothe fixed loop connection 402 via the system static loop connector 528.In this first loop-loading state, the flexible loop 524 is fixed fromrotating at the fixed loop connection 402 but rotates, in unison, withthe filler 460 at the loop connection area 454.

In FIG. 6B, the centrifuge assembly 400 is shown in a partially closedposition where the upper housing 404B is being moved from the openposition to a closed, or operational, position. As the upper housing404B pivots, the flexible loop 524 may move to a resting positionrelative to the centrifuge assembly 400. Although the flexible loop 524is rotationally fixed at the fixed loop connection 402, the filler 460may be free to rotate about the filler rotation axis 430B (e.g.,restricted only by the rotationally fixed flexible loop 524).

In FIG. 6C, the centrifuge assembly 400 is shown in a closed, oroperational, position where the upper housing 404B may be locked to thelower housing 404A (such that the lower housing 404A and the upperhousing 404B may rotate in unison about the centrifuge rotation axis430). In this position, the flexible loop 524 may pass from the loopconnection area 454 of the filler 460 through the loop access clearance436 of the centrifuge split-housing 404 to the fixed loop connection402. In at least one example embodiment, the flexible loop 524 may befree to move within the loop access clearance 436 with or withoutcontacting one or more portions of the centrifuge split-housing 404. Inthis position, as the centrifuge assembly 400 may rotate about thecentrifuge rotation axis 430, the flexible loop 524 rotationally fixedat the fixed loop connection 402 may twist along the length of theflexible loop 524 thereby rotating the filler 460 inside the centrifugeassembly 400 (e.g., along the centrifuge rotation axis 430). As providedabove, the rotation of the filler 460 relative to the centrifugeassembly 400 may be at a 2:1 ratio. For instance, as the centrifugeassembly 400 rotates one revolution, the rotationally fixed flexibleloop 524 (e.g., fixed at the fixed loop connection 402) twists at theloop connection area 454 (e.g., trying to unravel from being twisted bythe rotation of the centrifuge assembly 400, etc.) thereby rotating thefiller 460 in the same rotational direction as the centrifuge assembly400 but at substantially two revolutions. This rotation of the filler460, by the twisting of the flexible loop 524 along its length, requiresno gearing between the centrifuge assembly 400 and the filler 460.

Example Centrifuge Assembly in Loop-Loaded State

FIGS. 7A-7B show schematic plan views of the centrifuge assembly 400automatically loading a loop into an operational position (e.g., bloodseparation) for centrifuging. The centrifuge assembly 400 shown in FIGS.7A-7B may correspond to the centrifuge assembly 400 as previouslydiscussed and/or as described in conjunction with FIGS. 4A-4F and/orFIGS. 6A-6C. Once the blood component collection loop 520 has beenloaded into the centrifuge assembly 400, as illustrated in FIG. 6C, theflexible loop 524 may be automatically loaded into a loop engagedposition 520B as shown in FIGS. 7A-7B.

In at least one example embodiment, when the upper housing 404B islocked to the lower housing 404A, the flexible loop 524 may run from theloop connection area 454 of the filler 460 to the fixed loop connection402 of the apheresis system 200. Although the flexible loop 524 may berotationally fixed to the fixed loop connection 402 at the system staticloop connector 528, the flexible loop 524 passing through the loopaccess clearance 436 in the centrifuge split-housing 404 may notinitially be held, or at least partially captured, by the looprotational position guide 424 and/or other features of the centrifugeassembly 400. This state of the flexible loop 524 relative to the looprotational position guide 424, or loop arm, may correspond to anuncaptured loop state 700A. In other words, the flexible loop 524 may beoriented at some angle (α) relative to the loop rotational positionguide 424, loop position stop plate 704, and/or one or more loop twistsupport bearings 708, or bearing sets. In at least one exampleembodiment, the loop twist support bearing 708 may correspond to thebearings 417 described in conjunction with FIGS. 4B-4C. A loopcontainment area, or channel, may be formed by the loop position stopplate 704, and/or one or more loop twist support bearings 708 disposedalong a length of the upper housing 404B. In at least one exampleembodiment, this orientation may be engineered to allow access and/orease of loading during the loop-loading described in conjunction withFIGS. 6A-6C.

As the centrifuge assembly 400 is rotated in a loop and filler rotationdirection 712 about centrifuge rotation axis 430, the flexible loop 524may move from the uncaptured loop state 700A to the captured loop state700B shown in FIG. 7B. This rotation may be caused by an operatorrotating the centrifuge assembly 400 and/or the filler 460 in the loopand filler rotation direction 712 and/or by the rotor and motor assembly414 causing the centrifuge assembly 400 to rotate about the centrifugerotation axis 430. In at least one example embodiment, as the flexibleloop 524 rotates in the loop and filler rotation direction 712, an outerportion of the flexible loop 524 may contact a loop position stop plate704, or other rotational stop surface, of the loop rotational positionguide 424.

While the flexible loop 524 is held, or at least partially contained, inthe loop rotational position guide 424, a portion of the flexible loop524 may move within one or more of the loop twist support bearings 708.As described above, the flexible loop 524 may be rotationally fixed tothe fixed loop connection 402 via the first connector location feature530A of the system static loop connector 528 associated with the bloodcomponent collection loop 520. This rotationally fixed connectionprevents the flexible loop 524 from rotating relative to the apheresissystem 200 at the fixed loop connection 402. The other end of theflexible loop 524 may be interconnected at the loop connection area 454of the filler 460 where the end can move with the filler 460 and/orcentrifuge assembly 400. As the centrifuge assembly 400 continues torotate in the loop and filler rotation direction 712, the forces fromthe flexible loop 524 attempting to unravel, or keep from binding,rotate the filler 460 and the end of the flexible loop 524 attachedthereto.

In any event, once the fluid separation methods described herein arecompleted, the centrifuge assembly 400 may be stopped from rotating andthe centrifuge split-housing 404 can be opened to remove the disposableelements of the blood component collection set 500 from the centrifugeassembly 400. In some cases, the flexible loop 524 may be moved from thecaptured loop state 700B shown in FIG. 7B to the uncaptured loop state700A shown in FIG. 7A by rotating the centrifuge assembly 400 and/or thefiller 460 in a direction opposite the loop and filler rotationdirection 712.

Example Functional Diagram of an Example Apheresis System

A functional diagram of the apheresis system 200 may be as shown in FIG.8 in accordance with at least one example embodiment of the presentdisclosure. The description herein shows the components previouslydescribed, in FIGS. 1-7B, in a functional diagram to describe theoperation of the system 200 for extracting plasma or other bloodcomponents from the whole blood of a donor 102 during an apheresisprocedure or process.

The system 200 can include an anticoagulant (AC) pump 216. The AC pump216 pumps fluid in AC tubing 110 from the AC bag 114. The AC pump 216,the AC tubing 110, and/or the AC bag 114 may be as described previously.The AC tubing 110 may also include an AC air detection sensor (ADS) 804to detect air or fluid within the AC tubing 110. The AC ADS 804 may bethe same or similar in type and/or function to sensor 284 and/or sensor312, described previously. AC tubing 110 can intersect with and befluidly associated with the donor feed tubing 104 and the cassette inlettubing 108A at tubing connector 106. The tubing connector 106 can be anytype of connection between tubing 110, 104, and/or 108A, as describedpreviously.

The donor feed tubing 104 proceeds from the donor 102, where the donor102 may be stuck with a lumen needle or other device, allowing wholeblood to flow from the donor 102 into the apheresis system 200 andallowing blood components to flow back to the donor 102. Tubing 108A mayproceed to the soft cassette 340. Further, a donor air detection sensor312 can be placed on or in tubing 108A to detect the presence of fluidand/or air within tubing 108A.

As explained previously, the soft cassette 340 can include the firstcassette port 360A, which can function as, include, and/or besubstantially proximate to a “Y” connector or section, or branches, thatseparates the tubing 108A into the first bypass branch 358A and thefirst tubing section 368A (the “Y” section will be designated byreference character 360A). The two tubing sections 358 and 368 canreconnect at the second cassette port 360B, which can also function as,include, and/or be substantially proximate to a second “Y” connector orsection (the second “Y” section will be designated by referencecharacter 360B). Tubing 358 is bisected by the fluid sensor 316, whichseparates the tubing 358 into the first bypass branch 358A and thesecond bypass branch 358B. Likewise, tubing 368 is bisected by the dripchamber 354 that separates tubing 368 into a first tubing section 368Aand a second tubing section 368B.

The first tubing section 368A can include a first fluid control valve320A. The second tubing second 368B can likewise include a second fluidcontrol valve 320B. The first bypass branch 358A can similarly include adraw fluid control valve 320C. As such, the various sections of tubing368A, 358A, 358B, and 368B can be isolated by the valves 320A, 320B,and/or 320C based on the configuration of the system 200 and dependingon the operation of the system 200.

A drip chamber 354 may be disposed between the first tubing section 368Aand the second tubing section 368B. The drip chamber 354 can collect avolume of whole blood and/or high hematocrit blood (blood with a highpercentage of red blood cells) depending on the operation of the system200, as described hereinafter. The fluid sensor 316, as describedpreviously, may be disposed between the first bypass branch 358A and thesecond bypass branch 358B.

The inlet tubing 108B can connect to the second cassette port 360B andcan connect the soft cassette 340 to the flexible loop 524. The inlettubing 108B may also include a sensor 808, disposed on or in the tubing108B, placed with the tubing 108B before connecting with the systemstatic loop connector 528 of the flexible loop 524. The pressure sensor(CPS) 808 may detect one or more of, but not limited to: pressure,presence of fluid or air, and/or possibly another characteristic of thefluid in tube 108B. Further, a draw pump 208 can cause fluid to bepumped through tubing 108B either away from the soft cassette 340 or tothe soft cassette 340.

Two or more different tubes can be connected to the flexible loop 524through the system static loop connector 528 and provide fluid to, orreceive fluid from, the blood component collection bladder 536. A exittubing 112 exits the system static loop connector 528 from flexible loop524. This exit tubing 112 can also include another line sensor 812disposed thereon or therein to detect fluid, air, cellularconcentration, color, and/or color change in the fluid coming from theflexible loop 524; the line sensor 812 can be the same or similar intype and/or function to sensors 804, 312, 320, 808, and/or 284previously described. A second CPS sensor 816 or fluid sensor may alsobe disposed in or on line 112. Sensor 816 may detect one or more of, butnot limited to: the presence or absence of fluid, pressure within tubing112, and/or other characteristic of the fluid in tubing 112. Similarly,sensor 816 can be the same or similar in type and/or function to sensors804, 312, 320, 808, 812 and/or 284 previously described.

The exit tubing 112 may then flow into a plasma air detection sensor 284before the saline and plasma tubing y-connector 280 separates the exittubing 112 into saline tubing 116 and plasma tubing 120. The return pump212 may interact with the exit tubing 112 and can cause fluid or air toflow through the exit tubing 112 from either the flexible loop 524 orfrom a saline bag 118 and/or a plasma collection bottle 122.

The saline bag 118 and associated tubing can be as previously describedand can provide saline through the system 200 back to the donor 102. Asaline flow control valve 288 can isolate the saline bag 118 from therest of the system 200. Further, a plasma collection bottle 122 canreceive plasma from the flexible loop 524 when processed or separatedfrom the whole blood. The plasma collection bottle 122 can beselectively isolated from the system by the plasma flow control valve286.

Electrical and Control System

An embodiment of the electrical and control system 900 controlling thefunctions of the apheresis system 200 may be as shown in FIG. 9 inaccordance with embodiments of the present disclosure. The controlsystem 900 can include one or more nodes, which can include varioushardware, firmware, and/or software configured to control and/orcommunicate with the mechanical, electromechanical, and electricalcomponents of the apheresis system 200.

Each node may function to control a different part of the apheresissystem 200. For example, the control system 900 can include a cassettenode 904 which may be a soft cassette assembly system and a centrifugenode 908 that may be a centrifuge system, which may control orcommunicate with the components of the blood component collection set500 (and the associated hardware or mechanical components interfacingwith the soft cassette assembly 300) and the centrifuge assembly 400(and the associated hardware or mechanical components associatedtherewith), respectively. The cassette node 904 and centrifuge node 908may be in communication either wirelessly or through some otherelectrical or data connection. In some configurations, the cassette node904 and the centrifuge node 908 may be separate nodes that may be twoportions of a single node 902 or system. As such, each of the cassettenode 904 and the centrifuge node 908 may have the same physical hardwareoperating to control different functions. In at least one exampleembodiment, the single node 902 may include physical hardware for boththe cassette node 904 and the centrifuge node 908 or the cassette node904 may include physical hardware separate from physical hardware of thecentrifuge node 908. An example of the cassette node 904 may be asdescribed in conjunction with FIG. 10 ; a centrifuge node 908 may be asdescribed in conjunction with FIG. 11 .

Each of the cassette node 904 and the centrifuge node 908 may be incommunication with one or more sensors 916,920, and/or 924. There may bemore or fewer sensors than those shown in FIG. 9 , as represented byellipsis 928. Each of the cassette node 904 and the centrifuge node 908can communicate directly to each sensor 916-924 or may communicate withthe several sensors 916-924 via a bus 912. The bus 912 may communicateby any type of communication protocol, such as universal serial bus(USB), a universal asynchronous receive/transmit (UART), or other typesof bus systems or parallel communication connections. Thus, the bus 912may be optional, but is shown as a possible communication platform tocommunicate with the various sensors 916-924. The sensors 916-924 can beany type of sensor that can communicate information about light, fluid,the presence of air, color, pressure, etc., as described herein. Some ofthe sensors 916-924 can include sensors such as the air detection sensor312, the fluid sensor 316, the AC ADS 804, the pressure sensor 808, theline sensor 812, the second CPS sensor 816, and/or the air detectionsensor 284. The function of these sensors 912-924 may be as describedhereinafter.

The cassette node 904 and the centrifuge node 908 may also communicatewith one or more pump drives, pump motors, etc. 936,940,944, simplyreferred to as “pumps.” There may be more or fewer pumps than are shownin FIG. 9 , as represented by ellipsis 948. The cassette node 904 andthe centrifuge node 908 can communicate with the pumps 936-944 throughdirect wired or wireless communication or through a bus 932. The bus 932can be a control area network (CAN) bus, USB, or other type of busarchitecture to communicate with the pumps 936-944. The pumps 936-944can include or be a part of at least one of the draw pump 208, thereturn pump 212, and/or the AC pump 216, as previously described. Thefunction of the pumps 936-944 may be described as herein.

An embodiment of the cassette node 904 may be as shown in FIG. 10 inaccordance with embodiments of the present disclosure. The cassette node904 can include one or more of a controller 1004, a memory 1008, a valvecontroller 1020, and/or communication interfaces for a CAN bus 1016, aUART 1012, or other types of buses. The cassette node 904 can includeother hardware, firmware, and/or software that are not shown forclarity.

The controller 1004, also referred to herein as a processor, can be anytype of microcontroller, microprocessor, Field Programmable Gate Array(FPGA), Application Specific Integrated Circuit (ASIC), etc. An examplecontroller 1004 may be the NK10DN512VOK10 microcontroller, made and soldby N9P USA, Incorporated, which is a microcontroller unit with a 32-bitarchitecture. Other types of controllers are possible. The controller1004 can control other types of devices or direct the functions of othertypes of devices, such as valves such as the first fluid control valve320A, the second fluid control valve 320B, the draw fluid control valve320C, the plasma flow control valve 286, the saline flow control valve288, and the pumps 936-944, etc. Further, the controller 1004 cancommunicate with various sensors 916-924 or other devices to receive orsend information regarding the function of the apheresis system 200.

Other examples of the processors or microcontrollers 1004, as describedherein, may include, but are not limited to, at least one of Qualcomm®Snapdragon® 800 and 801, Qualcomm® Snapdragon® 610 and 615 with 4G LTEIntegration and 64-bit computing, Apple® A7 processor with 64-bitarchitecture, Apple® M7 motion coprocessors, Samsung® Exynos® series,the Intel® Core™ family of processors, the Intel® Xeon® family ofprocessors, the Intel® Atom™ family of processors, the Intel Itanium®family of processors, Intel® Core® i5-4670K and i7-4770K 22 nm Haswell,Intel® Core® i5-3570K 22 nm Ivy Bridge, the AMD® FX™ family ofprocessors, AMD® FX-4300, FX-6300, and FX-8350 32 nm Vishera, AMD®Kaveri processors, ARM® Cortex™-M processors, ARM® Cortex-A andARM926EJ-S™ processors, other industry-equivalent processors, and mayperform computational functions using any known or future-developedstandard, instruction set, libraries, and/or architecture.

The memory 1008 can be any type of memory including random access memory(RAM), read only memory (ROM), electrically erasable programmable ROM(EEPROM), a portable compact disc read-only memory (CD-ROM), an opticalstorage device, a magnetic storage device, any suitable combination ofthe foregoing, or other type of storage or memory device that stores andprovides instructions to program and control the controller 1004. Thememory 1008 may provide all types of software or firmware that programsthe functions of the controller 1004, as described hereinafter.

The controller 1004 can communicate with one or more valve controllers1020. Each valve such as such as the first fluid control valve 320A, thesecond fluid control valve 320B, the draw fluid control valve 320C, theplasma flow control valve 286, the saline flow control valve 288, asdescribed herein, may be controlled by a valve controller 1020 and maybe associated with a component of the system 200, as described herein.The valve controller 1020 can provide the electrical signal, operationaldirective, or power to close or open any one of the valves describedherein, for example, the saline and plasma valve housing 276, the plasmaflow control valve 286, the saline flow control valve 288, the firstfluid control valve 320A, the second fluid control valve 320B, and/orthe draw fluid control valve 320C, etc.

The controller 1004 can also be connected to a bus 912,932 (e.g., UARTbus, CAN bus), or other busses through transceivers 1012,1016 providedoutside of the controller 1004 or integral to the controller 1004. TheUART transceiver 1012 may communicate with one or more of the sensors916-924 or other devices. Likewise, the CAN bus transceiver 1016 cancommunicate with one or more of the pump controllers 936-944 or otherdevices. UART transceivers 1012 and busses and CAN bus transceivers 1016and busses are well known in the art and need not be explained furtherherein.

An embodiment of the centrifuge node 908 may be as shown in FIG. 11 , inaccordance with embodiments of the present disclosure. The centrifugenode 908, can include the same or similar types of components as thecassette node 904. For example, the centrifuge node 908 can include acontroller 1104, a UART transceiver 1112, etc. Similar to the controller1004, the controller 1104 can be any type of processor ormicrocontroller, for example the NK10DN512VOK10 microcontroller unitwith 32-bit architecture from N9P USA, Incorporated, as mentionedpreviously, or other controllers, processors, etc., for example, thedevices mentioned previously.

The controller 1104 can communicate with the sensors 916-924 directly,through the UART transceiver 1112, or through other busses or systems.The controller 1104 can also communicate with a brake controller 1124that can brake or slow and stop the centrifuge 400. Likewise, acontroller 1104 can communicate with a motor transceiver 1116 thatcommunicates with a motor power system or a motor controller thatfunctions to spin up or rotate the centrifuge 400 or control the speedsetting or other function of the centrifuge 400.

In some configurations, the controller 1104 can also communicate with acuff controller 1120 that can change or set the pressure of a pressurecuff on a donor's arm during the apheresis process. Further, thecontroller 1104 can communicate with and/or control a strobe light 1114,which can be any light that flashes at a periodicity in synchronicitywith the rate of spin of the motor, such that an operator of theapheresis system 200 can see the operation of the filler 460, asdescribed previously. Thus, the controller 1104 can communicate with thestrobe light 1114 to change the frequency of the flashing of the strobelight 1114, the intensity of the strobe light 1114, etc.

As should be understood the cassette node 904 and the centrifuge node908 include additional components such as described in Atty. Docket No.18955-000019-US, titled “METHODS AND SYSTEMS FOR HIGH-THROUGHPUT BLOODCOMPONENT COLLECTION”, filed on Aug. 3, 2021 and assigned applicationSer. No. 17/392,804, the entire contents of which are hereinincorporated by reference.

Example Code Scanning and Data Control Methods

In at least one example embodiment, a data entry process, as illustratedin FIG. 12A, may be used to initialize an apheresis system 200 for eachnew donor 102. The data entry process may ensure a target amount orvolume of plasma based on donor weight or other donor information isobtained. Also, information such as bottle identification may be enteredthrough the data entry process such that the apheresis system may becapable of recording in memory an indication as to which bottle was usedfor which donor.

In at least one example embodiment, the process of FIG. 12A may begin at1200 in which the apheresis system 200 may be powered on and waiting fora new donor. The apheresis system 200 may include an integratedidentification reader (e.g., RFID reader, barcode reader, etc.) 1221, asillustrated in FIG. 12B, configured to read a code (e.g., RFID tag,barcode, etc.) associated with a particular donor 102 and controloperations of the apheresis system 200 based on the information read bythe identification reader. The information may include but is in no waylimited to individual donor data (e.g., body mass index (BMI), 1st timedonor, weight, height, etc.). This information may be used for fasterand higher quality donor experiences. Codes may also be used to labelother equipment used during the donation process, such as a label 1227on a bottle 1224 used for plasma collection as illustrated in FIG. 12C.

At 1203, the reader 1221 of the apheresis system 200 may be used to scana barcode, QR code, or other type of image to receive data associatedwith a donor. In at least one example embodiment, the reader 1221 may beconfigured to read input from an RFID. For example, the donor may use anID card or other type of object which may comprise one or more of abarcode, QR code, RFID, etc. By scanning the ID card or other type ofobject, the apheresis system 200 may be enabled to receive data relatingto the donor.

Barcodes (e.g., 1D, 2D, etc.) may be read by an integrated barcodescanner disposed on a front of the apheresis system. For example, whenstarting the apheresis procedure, a user may scan a donor ID (e.g., froma PDA, phone, tablet, etc.), a blood component collection set (e.g.,separation set), and/or a plasma collection bottle, sequentially andwithout requiring further input from the user via the user interface.The system may be enabled to receive the information and confirm entryof the data automatically and without human input. As can beappreciated, this automatic sequential intake of data increases thespeed of the operation compared to conventional nonsequential inputting.

Data received from the donor may comprise biological information such asage, weight, height, donor history, or other information which may berelevant to the donation process. The data received from the donor maybe used to determine whether the donor qualifies for the donationprocedure and to determine particular settings which may be required forthe donation procedure, such as a total expected amount of plasma orother information. For example, the height and weight of the donor maybe used to determine a body mass of the donor. The body mass of thedonor may then be used to determine the target amount or volume ofplasma to be collected.

In at least one example embodiment, the information may be portablebetween donation sites, apheresis systems 200, locations, etc. Theinformation may be stored in the form of a nomogram, for example, in a2D barcode. In this way, a donor may be enabled to carry a single formof identification between donation sites and each donation site may beenabled to collect information about the donor, such as time since thelast visit.

The information stored in the nomogram, and that is capable of beingread by the integrated identification reader, may be limited toinformation that the apheresis system 200 is allowed to collect (e.g.,by privacy laws, health laws, etc.). In at least one example embodiment,other private information may be stored in the 2D barcode, but may beencrypted, or locked, from being read by the integrated identificationreader of the apheresis system 200.

The apheresis system 200 may scan, or read, the barcode and thendetermine what operations to perform. For example, the barcode maycontain information regarding the weight and the height of the donor102, which may be used to define the amount or volume of plasma thedonor 102 can provide or donate. As can be appreciated, a donor 102having a first weight may be allowed to donate a first amount of plasmawhile a donor 102 having a heavier second weight may be allowed todonate a second amount of plasma that is greater than the first amount.Additionally, the body mass of the donor 102 may be used to define theamount or volume of plasma the donor 102 can provide or donate. Once theapheresis system 200 reads the barcode, the apheresis system 200 canadjust the settings based on the information, and cease operations whenthe requisite amount of plasma, etc., is collected.

The apheresis system 200 may also be enabled to write information whichmay be read by other apheresis systems in the same or other donationsites. For example, donor data may be stored at a network location. Theapheresis system 200 may be enabled to send data such as donationresults, a current weight of the donor, a date and/or time of thedonation, or other information.

In at least one example embodiment, the apheresis system 200 maycomprise one or more computer systems. For example, as will be discussedin greater detail below with respect to FIG. 16D, the apheresis system200 may include one or more computer systems 1627 which may comprise aprocessor 1630, memory 1633, input/output devices 1636, one or more pumpcontrol systems 1639, one or more sensors 1642, and/or other elements ascan be appreciated.

In at least one example embodiment, as will be discussed in greaterdetail below with respect to FIG. 16B, the apheresis system 200 may beenabled to communicate with a server 1621 via a network 1618, such asthe Internet. In at least one example embodiment, the apheresis system200 may communicate with a local computer system, such as a computer onlocation at a donation site, which may be configured to communicate withthe server.

In at least one example embodiment, after receiving the data associatedwith the donor, the apheresis system 200 may confirm receipt of the dataassociated with the donor through a feedback system such as a graphicaluser interface (GUI) 1230, as illustrated in FIGS. 12B and 12D. In thisway, a nurse, practitioner, or other user of the apheresis system 200may be enabled to quickly ascertain whether the donor information hasbeen properly inputted into the apheresis system 200. In at least oneexample embodiment, the feedback system may also or alternativelycomprise a speaker which may be configured to provide audible feedback.

At 1206, the apheresis system 200 may be configured to determine, basedon the data associated with a donor, an identification of the donor. Forexample, the apheresis system 200 may be configured to identify, usingthe data received via the scanner 1221, whether the donor is associatedwith any donor ID information in a database or whether the donor is anew donor. In at least one example embodiment, the scanner 1221 mayaccess donor information from a server or other computer system eitherlocally or via a network connection.

Donor ID information accessed via a database may comprise informationsuch as age, body mass, weight, height, and/or a target volume, i.e., anexpected amount of plasma, or other donation fluid, to be received fromthe donor.

At 1209, the apheresis system 200 may receive data associated with ablood component collection set. The blood component collection set maycomprise, for example, a soft cassette assembly, such as the softcassette assembly 300, to be used during the donation process. The dataassociated with the blood component collection set may be received bythe apheresis system 200 via a barcode, a QR code, an RFID chip, orother type of scannable object which may be placed on the bloodcomponent collection set. For example, each blood component collectionset may be affixed with a label or sticker which may include a distinctbarcode, QR code, RFID chip, or other type of scannable object. Byscanning the label or sticker on the blood component collection set, theapheresis system 200 may be enabled to record into memory which bloodcomponent collection set is being used for the current donation process.In this way, the apheresis system 200 may be enabled to associate donorwith a blood component collection set. Any data received during thescanning process may be recorded into memory and shared with a server orother type of computing system.

The data associated with the blood component collection set may comprisea date of manufacture, an identity of manufacturer, for otherinformation which may be useful for data processing purposes after thedonation is complete. In at least one example embodiment, dataassociated with the blood component collection set received throughscanning may be used to determine a type of blood component collectionset. The type of blood component collection set may be used by theapheresis system to adjust one or more settings such as flow rate orother information during the donation process.

In at least one example embodiment, after scanning the blood componentcollection set, a user of the apheresis system 200 may be enabled toreceive confirmation of the receipt of the information from the bloodcomponent collection set. For example, a graphical user interface 1230,as illustrated in FIG. 12D, may display an indication as to whether datafrom a blood component collection set has been received. Such agraphical user interface 1230 may be used by an operator of theapheresis system during the process of initializing the apheresis systemfor a new donor. In at least one example embodiment, instead of or inaddition to displaying through a graphical user interface, the apheresissystem may play an audible sound through one or more speakers or displaylights of various colors to indicate the data has been received.

At 1212, the method may comprise receiving, with the apheresis system200, data associated with a plasma collection bottle. For example, toinitialize the apheresis system 200 for a new donor, a plasma collectionbottle may be required. After donation, the plasma collection bottle maybe filled with the donated plasma. For data tracking purposes, theplasma collection bottle may be required to be associated with thedonor. For example, information linking the donor to the plasmacollection bottle may be stored in memory. For this reason, it may benecessary for an identity of the plasma collection bottle to berecorded. As such, a user of the apheresis system 200 may be enabled toscan a label, sticker, or other object on or printed on the plasmacollection bottle using the apheresis system 200. For example, asillustrated in FIG. 12C, a plasma collection bottle 1224 may be affixedwith a sticker or label 1227. In some example embodiments, the stickeror label 1227 includes a QR code.

As with other steps, upon receiving data from a plasma collectionbottle, the apheresis system 200 may acknowledge receipt of the data viaa graphical user interface, speaker, white, or other feedback system.

At 1215, the apheresis system may perform a plasma donation processbased on the information received in the above steps. For example, theapheresis system 200 may perform the plasma donation process usinginformation about the identity of the donor. Data received from theplasma collection bottle and/or the blood components may also be usedduring the plasma donation process.

For example, a rate of flow during the plasma donation process may becontrolled based on one or more of a body mass and a weight of the donordetermined based on the received data associated with the donor. Avolume of plasma collected may also be controlled based on one or moreof a body mass and a weight of the donor determined based on thereceived data associated with the donor.

At 1218, the process may end, at which point the donation process maycontinue with the extraction of fluids from the donor being completed.Any data received through the steps discussed above may be recorded intomemory and/or shared with one or more computer systems. For example, adatabase entry may be created for the particular donation, includinginformation such as an amount or volume of plasma extracted from thedonor, a current weight of the donor, a time and/or date of thedonation, and/or other information.

At least one example embodiment of the present disclosure includes amethod comprising: receiving, with an apheresis system, data associatedwith a donor; determining, based on the data associated with a donor, anidentification of the donor; receiving, with the apheresis system, dataassociated with a blood component collection set; receiving, with theapheresis system, data associated with a plasma collection bottle; andperforming, with the apheresis system, a plasma donation process basedon the identification of the donor, the data associated with the bloodcomponent set, and the data associated with the plasma collectionbottle.

Aspects of the above embodiment include wherein receiving the dataassociated with the donor comprises scanning, with a scanner, an image.Aspects of the above embodiment include wherein the scanner is disposedon the apheresis system. Aspects of the above embodiment include whereinthe image is one of a one-dimensional barcode and a two-dimensionalbarcode. Aspects of the above embodiment include wherein the image isdisplayed on a user device. Aspects of the above embodiment includewherein receiving the data associated with the donor comprises scanningan RFID. Aspects of the above embodiment include, after receiving thedata associated with the donor, confirming receipt of the dataassociated with the donor through a feedback system. Aspects of theabove embodiment include wherein the feedback system comprises one ormore of a speaker and a graphical user interface. Aspects of the aboveembodiment include determining, based on the data associated with thedonor, the donor is a new donor Aspects of the above embodiment includedetermining, based on the data associated with the donor, one or more ofa body mass and a weight of the donor Aspects of the above embodimentinclude wherein receiving the data associated with the blood componentcollection set comprises scanning, with a scanner, one or an image andan RFID attached to the blood component collection set. Aspects of theabove embodiment include, after receiving the data associated with theblood component collection set, confirming receipt of the dataassociated with the blood component collection set through a feedbacksystem. Aspects of the above embodiment include wherein the feedbacksystem comprises one or more of a speaker and a graphical userinterface. Aspects of the above embodiment include wherein receiving thedata associated with the plasma collection bottle comprises scanning,with a scanner, one or an image and an RFID attached to the plasmacollection bottle. Aspects of the above embodiment include, afterreceiving the data associated with the plasma collection bottle,confirming receipt of the data associated with the plasma collectionbottle through a feedback system. Aspects of the above embodimentinclude wherein the feedback system comprises one or more of a speakerand a graphical user interface. Aspects of the above embodiment includewherein a rate of flow during the plasma donation process is controlledbased on one or more of a body mass and a weight of the donor determinedbased on the received data associated with the donor.

Example Calibration, Maintenance, and Service of Apheresis Systems

The apheresis system 200 may comprise one or more devices, systems,and/or features that are configured to allow the apheresis system 200 tobe calibrated in the field. For example, the apheresis system 200 maycomprise one or more devices, systems, and/or features that areconfigured to allow the apheresis system 200 to be calibrated in thefield. Stated another way, the apheresis system 200 may be calibratedafter manufacturing and after being installed in a donor processinglocation. Conventional systems provide no way of being calibrated whilein the field.

In at least one embodiment, the apheresis system 200 may beself-calibrating. The apheresis system 200 may comprise a pump andsyringe that utilizes pressure supplied from a compressor integratedwith the apheresis system 200, for example, to set a calibrationpressure. In other embodiments, the compressor may not be integratedwith the apheresis system 200 and may be a component separate from theapheresis system 200. The apheresis system 200 may also include a testport that is configured to generate a known or calibration pressureusing, for example, the pump and the compressor. In at least one exampleembodiment, the test port is positioned on a back side of the apheresissystem 200 adjacent other ports, such as a pressure cuff connection thatcan change or set the pressure of a pressure cuff on a donor's armduring the apheresis process, as set forth above with respect to FIG. 11. Tubing of a blood component collection loop 520, calibration tube set,etc., may be attached or otherwise interconnected to the test port fortesting and/or calibration. When interconnected with the test port, thecompressor generates the known calibration pressure, and a pressuresensor in the apheresis system 200 may calibrate based on the detectedpressure by the pressure sensor. For example, the known calibrationpressure may be compared to the detected pressure and the difference maybe used to calibrate the pressure sensor. The pressure sensor may belocated at, for example, the test port, or may be located anywhere inthe apheresis system 200.

Calibration may also comprise using a calibration object with a knownweight (such as, for example, a NIST weight) to check and/or calibrate aholder, such as the holder 1300 shown in FIG. 13A and/or the bottle trayload cell assembly shown in FIGS. 15A-15C, which will be discussed ingreater detail below. In at least one example embodiment, the holder1300 may be configured to receive the plasma collection bottle 122. Theholder 1300 may be disposed on the top cover 210 of the housing 204 andmay be may be similar to the plasma collection cradle 232C, as shown inFIG. 14A. The holder 1300 may comprise a weight sensor configured tosense a weight of an object placed on the holder 1300. As such, during acalibration, the calibration object may be placed on the holder 1300 andthe weight sensor may detect the weight of the calibration object. Adifference in the known weight of the calibration object and thedetected weight as detected by the weight sensor may indicate that theweight sensor may need calibration (which may be automatically triggeredby the difference) or service. In at least one example embodiment, ifthe difference is greater than a predetermined threshold, then theapheresis system 200 may automatically trigger calibration of the weightsensor. In other embodiments, a notification may be generated to alert auser to calibrate the weight sensor if the difference is greater thanthe predetermined threshold.

Calibration test(s) and/or calibration may be performed when one or morecomponents are exchanged or swapped on the apheresis system 200. Forexample, exchanging or replacing one or more pumps (e.g., pumps 208,212, 216) may trigger the calibration test(s). Calibration (whether ofthe pressure, sensors, weight, etc.) may be automatically performed ifone or more components of the apheresis system 200 does not pass thecalibration test(s). If the calibration of one or more components isunsuccessful, the apheresis system 200 may be locked and may not be useduntil each component passes its respective calibration test.

The method 1302 for performing a calibration test and calibrationillustrated by the flowchart of FIG. 13B may begin at 1304. At thebeginning of the method 1302, one or more calibration test(s) may beperformed or executed. The calibration test(s) may be automaticallytriggered by exchanging or replacing one or more components (e.g., oneor more sleds, sensors, pumps, etc.) of an apheresis system, such as theapheresis system 200. In other example embodiments, the calibrationtest(s) may be triggered by user input. In still other exampleembodiments, the calibration tests may be performed prior to use of theapheresis system 200.

At 1306, one or more components of the system (e.g., calibration tubing,sensors, pumps, etc.) may be automatically calibrated. The calibrationmay be triggered by, for example, failure of at least one test of theone or more tests executed in the step 1304. In other exampleembodiments, the calibration may be triggered by user input. Thecalibration may be executed using one or more calibration tools such as,for example, a pump, a test port, a calibration object, or the like. Thecalibration may cause a user interface such as a graphical userinterface (GUI) to alert a user to connect one or more calibrationtooling(s) or components to run the calibration.

It will be appreciated that the step 1304 and 1306 may be repeated(whether separately or together). For example, a component may fail acalibration test in step 1304, the component may be automaticallycalibrated in the step 1306, and the component may be retested in thestep 1304 to test whether the component was properly calibrated.

The apheresis system 200 may also include one or more protocols toservice the device. These protocols may include Calibrate (describedabove), Auto-Test (e.g., testing limits and full range), Fluid Run (withactual parameters), and/or the like. In at least one example embodiment,a saline check may be executed. In such embodiments, the apheresissystem 200 may comprise a weight sensor configured to sense a weight ofthe plasma collection bottle 122. Saline may be moved from the salinebag 118 to the plasma collection bottle 122 and a change in the weightof the plasma collection bottle 122 may be detected by the weightsensor. Such a change in weight indicates that saline is properlyflowing from the saline bag 118, through the saline tubing 116, and tothe plasma collection bottle 112. In at least one example embodiment, adisposable test may be executed to check the blood component collectionset 500 for leaks. In such embodiments, the apheresis system 200 mayinclude a pump configured to form a vacuum in the blood componentcollection set 500. The apheresis system 200 may also include a sensorfor detecting such leaks in the blood component collection set 500. Inat least one example embodiment, a centrifuge test may be executed totest the centrifuge assembly 400. In such embodiments, a motor of therotor and motor assembly 414 may be activated to validate properrotation of the centrifuge assembly 400.

Example Moving Loop Holder

FIGS. 14A-14F illustrate a moving loop holder 1400 as included in theapheresis system 200. As illustrated, the moving loop holder 1400 may beat least partially disposed within the centrifuge chamber 1402 of theapheresis system 200. The centrifuge chamber 1402 is defined as theinterior space of the apheresis system 200 where the centrifuge assembly400 is housed and, for example, as located behind the access panel 224.As illustrated in FIG. 14B, the moving loop holder 1400 may be arrangedabove the centrifuge assembly 400 (e.g., offset from the centrifugeassembly 400 in the positive z-axis direction). The moving loop holder1400 may correspond to the fixed loop connection 402, or a portion ofthe fixed loop connection 402, as described above.

The moving loop holder 1400 may include a loop holder body (alsoreferred to as a loop holder) 1408 having a loop connection space (alsoreferred to as a loop connection) 1412. A portion of the blood componentcollection set 500 may be held by the loop connection space 1412. Forexample, as illustrated for example in FIG. 14C, the loop connectionspace 1412 may be configured to receive or capture a portion of theflexible loop 524, the system static loop connector 528, or acombination thereof. In at least one example embodiment, a connectorlock wheel 1424 and flange 1428 may work to lock (positively) the systemstatic loop connector 528 within the loop connection space 1412. Forexample, as illustrated, the system static loop connector 528 and/or theflexible loop 524 may be disposed between the connector lock upper wheel1424 and the flange 1428 and the connector lock upper wheel 1424 may bemoved relative to the flange 1428 to apply a holding pressure to thesystem static loop connector 528 and/or the flexible loop 524. In atleast one example embodiment, the moving loop holder 1400 may allow fora shorter distance of the flexible loop 524 to be used in the bloodcomponent collection set 500 than would be required absent the movingloop holder 1400. In certain variations, the shorter distance may loweran effective circulating volume of the blood component collection set500. The shorter distance may reduce waste, for example, from materialsused to make the blood component collection set 500, blood componentsremaining in the blood component collection set 500 after use, and thelike. The shorter distance may provide a controlled length of theflexible loop 524 such that the flexible loop 544 resists tangling,catching, and/or ensures proper loading in the apheresis system 200.

The moving loop holder 1400 may be movable (using an automated processor a manual process) between a first or operational or extended state(see, e.g., FIGS. 14A-14B and 14D) and a second or load or restrictedstate (see, e.g., 14E). For example, the moving loop holder 1400 may bemoveable (along the x-axis) from an extended position near a first orfront side 202 of the apheresis system 200 to or towards a second orrear side 206 of the apheresis system 200. While in the extendedposition, the moving loop holder 1400 may be fixedly coupled to theblood component collection loop 520. While in the retracted position,the blood component collection loop 520 may be detached or disconnectedfrom the loop holder body 1408. For example, the moving loop holder 1400may include a release latch 1404 may be actuated (e.g., pulled,unlatched, etc.) unlocking the moving loop holder 1400 from a first orlocked state to a second or unlocked state. In the unlocked state, theloop holder body 1408 may be moved in a retraction direction 1420 (e.g.,away from the front 202 and toward a rear 206 of the apheresis system200 and/or housing 204). The retraction direction 1420 may be definedalong both the x-axis and the z-axis in the XZ-plane.

In at least one example embodiment, as illustrated for example in FIG.14E, the retraction of the moving loop holder 1400 may provide clearancefor the upper housing 404B to pivot from an interior of the centrifugechamber 1402 to a position outside of the centrifuge chamber 1402(compare, e.g., FIGS. 4D and 4E and 4F). For example, when the loopholder body 1408 is moves in the retraction direction 1420, the loopholder body 1408 may be positioned outside of a filler opening pivot arc1410, which is illustrated in FIG. 14C as an arcuate centerline thatpivots, for example, about the y-axis). A pivot clearance space 1416 maybe disposed between the loop holder body 1408 and the filler openingpivot arc 1410. The pivot clearance space 1416 may allow the upperhousing 404B to pivot relative to the lower housing 404A as thecentrifuge split-housing 404 moves between an operating state and aloading state and vice versa (e.g., without the upper housing 404Bcontacting the loop holder body 1408, etc.). For example, when themoving loop holder 1400 is in a retracted position, the upper housing404B may hinge and invert to allow the filler 460 to be loaded, forexample, with a blood component collection loop 520 and blood componentcollection bladder 536. Once loaded, the upper housing 404B may beclosed and secured in an operational state. When the upper housing 404Bis secured in the operational state (e.g., the upper housing 404B andthe lower housing 404A are connected), the moving loop holder 1400 maybe extended (e.g., moved to the extended state) to hold the bloodcomponent collection loop 520, for example, in a fixed position relativeto the centrifuge assembly 400.

In at least one example embodiment, when the moving loop holder 1400 isarranged in the extended state, the loop holder body 1408 may be offseta first distance 1430A from the centrifuge assembly 400 including theupper housing 404B preventing the upper housing 404B from moving betweenan operating state and a loading state and or vice versa. For example,when the loop holder body 1408 is offset the first distance 1430A in theextended state, the upper housing 404B would contact the loop holderbody 1408 if the upper housing 404B hinges relative to the lower housing404A. To move the centrifuge assembly 400 between the operating stateand the loading state, the moving loop holder 1400 needs to be firstmoved to the retracted state 1400B. When the moving loop holder 1400 isin the retracted state 1400B, for example, as illustrated in FIG. 14C,the retracted loop holder body 1408′ may be offset a second distance1430B from the centrifuge assembly 400. The second distance 1430B may begreater than the first distance 1430A and may define the pivot clearancespace 1416 between the loop holder body 1408 and the filler openingpivot arc 1410. The filler opening pivot arc 1410 may correspond to apath associated with an outermost portion of the upper housing 404B asthe upper housing 404B hinges about the split-housing pivot axis 406(e.g., relative to the lower housing 404A, etc.). While the moving loopholder 1400 is in the retracted state 1400B, the upper housing 404B maybe hinged relative to the lower housing 404A without contacting the loopholder body 1408.

In at least one example embodiment, when the moving loop holder 1400 isin the retracted state 1400B, the apheresis system 200 may be unable tooperate. The apheresis system 200 may only be allowed to operate whenthe moving loop holder 1400 is in the extended state. For instance, theapheresis system 200 may include one or more sensors configured todetect a position of the moving loop holder 1400 and, based on thedetected position, provide an input including information about theposition of the moving loop holder 1400 to the controller of theapheresis system 200. In response, the controller may restrict operationof the apheresis system 200 when the moving loop holder 1400 is in theretracted state while allowing operation of the apheresis system 200when the moving loop holder 1400 is in the extended state.

The apheresis system 200 may be loaded with a portion of a bloodcomponent collection set 500 by moving the moving loop holder 1400 tothe retracted state 1400B and hinging the upper housing 404B to theloading position (see, e.g., FIGS. 4F and 6A). In at least one exampleembodiment, when the upper housing 404B is opened and in the loadingstate, at least a portion of the upper housing 404B may extend outsideof the centrifuge chamber 1402. In this “flipped” loading state theinverted upper housing 404B may provide clearance and accessibility forloading the blood component collection bladder 536 in the filler 460(e.g., disposed in the upper housing 404B), as described above. When theblood component collection loop 520 is connected, or otherwise coupled,to the filler 460, the upper housing 404B may be hinged from the loadingstate to the operating state (see, e.g., FIG. 6C). In this position themoving loop holder 1400 may be moved from the retracted state 1400B tothe extended state (see, e.g., FIG. 14C) and the system static loopconnector 528 of the blood component collection loop 520 may beinterconnected with the loop connection space 1412 of the loop holderbody 1408. Unloading the filler 460 may be performed by reversing theorder of above-described operations. For example, unloading the filler460 and/or the centrifuge assembly 400 may include uncoupling the systemstatic loop connector 528 from the loop connection space 1412 and movingthe loop holder 1400 from the extended state to the retracted state1400B. Once in the retracted state 1400B, the upper housing 404B may berotated, or hinged, from the operating position to the open loadingposition. In the open position, the blood component collection loop 520may be disconnected and removed from the filler 460. The process ofloading and unloading may repeat to reload the filler 460 and/or thecentrifuge assembly 400 between uses, or operations, of the apheresissystem 200.

In at least one example embodiment, the present disclosure provides anapheresis system. The apheresis system may include a housing having afront side and a rear side, a centrifuge chamber disposed in thehousing, a centrifuge assembly disposed in the centrifuge chamber, and amoving loop holder disposed in the centrifuge chamber, where the movingloop holder includes a loop holder body and a loop connection spacedisposed in the loop holder body. The loop connection space may be sizedto receive a connector of a flexible loop. The moving loop holder may bemoveable between an extended state inside the centrifuge chamber and aretracted state inside the centrifuge chamber, where in the extendedstate, the loop holder body is arranged offset a first distance from thecentrifuge assembly, and in the retracted state, the loop holder body isarranged offset a second distance from the centrifuge assembly and thesecond distance is larger than the first distance. In at least oneexample embodiment, the centrifuge assembly may include a centrifugehousing, and the centrifuge housing may include a loading state and anoperating state. The centrifuge housing may be prevented from movingfrom the operating state to the loading state when the moving loopholder is in the extended state, and the centrifuge housing may beallowed to move from the operating state to the loading state when themoving loop holder is in the retracted state. In at least one exampleembodiment, the centrifuge housing may include a split housing thatincludes a lower housing portion and an upper housing portion, where theupper housing portion hinges relative to the lower housing portion, andthe upper housing portion hinges along an arc when moving between theoperating state and the loading state. In at least one exampleembodiment, when the moving loop holder is in the retracted state, aclearance space may be disposed between the loop holder body and the arcso as to provide a movement path along the arc for the upper housingportion to hinge relative to the lower housing portion between theoperating state and the loading state clear of the loop holder body. Inat least one example embodiment, when the moving loop holder is in theextended state, the clearance space may be removed between the loopholder body and the arc may prevent the upper housing portion fromhinging relative to the lower housing portion between the operatingstate and the loading state. In at least one example embodiment, whenthe moving loop holder is in the retracted state, the loop holder bodymay be disposed closer to the rear side of the housing than when themoving loop holder is in the extended state. In at least one exampleembodiment, the loop holder body may include a connector lock thatengages with the connector of a flexible loop locking the flexible looprelative to the loop holder body and the loop connection space. In atleast one example embodiment, the moveable loop holder may include aloop holder body and a loop connection space disposed in the loop holderbody. The loop connection space may be sized to receive a connector of aflexible loop of a blood component collection set. The moveable loopholder may be moveable between an extended state inside a centrifugechamber of an apheresis system and a retracted state inside thecentrifuge chamber, where in the extended state, the loop holder body isarranged offset a first distance from a centrifuge assembly disposed inthe centrifuge chamber, and in the retracted state, the loop holder bodyis arranged offset a second distance from the centrifuge assemblydisposed in the centrifuge chamber. The second distance may be largerthan the first distance. In at least one example embodiment, the loopholder body may include a connector lock that engages with the connectorof a flexible loop so as to lock the flexible loop relative to the loopholder body and the loop connection space.

In at least one example embodiment a method for loading a centrifugefiller of an apheresis system is provided. The method may includeproviding an apheresis system that includes a housing having a frontside and a rear side, a centrifuge chamber disposed in the housing, acentrifuge assembly disposed in the centrifuge chamber, and a movingloop holder disposed in the centrifuge chamber. The centrifuge assemblymay have a split housing that includes a lower housing portion and anupper housing portion, where the upper housing portion hinges relativeto the lower housing portion. The centrifuge housing may have a loadingstate and an operating state. The moving loop holder may include a loopholder body and a loop connection space disposed in the loop holderbody. The loop connection space may be sized to receive a connector of aflexible loop. The moving loop holder may be moveable between anextended state inside the centrifuge chamber and a retracted stateinside the centrifuge chamber, where in the extended state, the loopholder body may be arranged offset a first distance from the centrifugeassembly, and in the retracted state, the loop holder body is arrangedoffset a second distance from the centrifuge assembly. The seconddistance may be larger than the first distance. The upper housingportion may hinge along an arc when moving between the operating stateand the loading state, where the split housing may be prevented frommoving from the operating state to the loading state when the movingloop holder is in the extended state, and the split housing may beallowed to move from the operating state to the loading state when themoving loop holder is in the extended state. The method for loading acentrifuge filler may further include actuating a release latch so as tounlock the moving loop holder from a locked state to an unlocked state;moving the moving loop holder from the extended state to the retractedstate; hinging, while the moving loop holder is in the retracted state,the upper housing portion relative to the lower housing portion suchthat the upper housing portion is at least partially disposed outside ofthe centrifuge chamber and the upper housing portion is in the loadingstate; coupling a blood component collection bladder and flexible loopof a blood component collection set with a filler disposed in the upperhousing portion while the upper housing portion is in the loading state;hinging, while the moving loop holder is in the retracted state, theupper housing portion relative to the lower housing portion such thatthe upper housing portion is disposed inside of the centrifuge chamberand the upper housing portion is in the operating state; and moving themoving loop holder from the retracted state to the extended statecausing the release latch to lock the moving loop holder in the lockedstate.

Example Bottle Tray with Magnetic Coupling and Load Cell OverloadProtection

FIGS. 15A-15M show various views of a load cell assembly and componentsthereof according to at least one example embodiment. FIG. 15A is aperspective view of the load cell assembly according to at least oneexample embodiment. FIG. 15B is an exploded perspective view of the loadcell assembly of FIG. 15A according to at least one example embodiment.

In at least the example embodiment shown, the load cell assembly 1500 isa bottle tray load cell assembly. The load cell assembly 1500 includes afixed portion, a deflection portion (FIG. 15B), and a load cell 1506. Inat least one example embodiment, the fixed portion includes a plate 1508(also referred to as a “mount plate”) and a bracket 1510 (also referredto as a “load cell support bracket”). In at least one exampleembodiment, the deflection portion includes a first component 1512 (alsoreferred to as a “load interface plate”), a second component 1514 (alsoreferred to as an “overload support bar”), and a cradle 1516 (alsoreferred to as a “bottle cradle” or a “plasma collection cradle”). Theload cell assembly 1500 may extend along a central or longitudinal axis1517. In at least one example embodiment, the longitudinal axis 1517passes through a center of the load cell 1506.

In at least one example embodiment, the cradle 1516 may be similar tothe plasma collection cradle 232C of FIG. 2A. The plasma collectioncradle 1516 may be attached to the overload support bar 1514. Asdescribed above, the plasma collection cradle 1516 may be configured toreceive, orient, and/or hold a vessel, such as a plasma collectionbottle (e.g., bottle 1598 of FIG. 15M or vessel 2716 if FIG. 26J), in anapheresis system, such as the apheresis system 200 shown in (FIG. 1A).In at least one example embodiment, the load cell 1506 is configured todeflect and sense a load and/or weight of a vessel. The load cell 1506may be sensitive to forces within a predetermined (or alternatively,desired) range. For example, when forces applied to the load cell 1506are below outside of predetermined range (e.g., over), the accuracy ofthe load measurements and/or integrity of the load cell 1506 may becompromised.

In at least one example embodiment, the cradle 1516 is coupled to theload cell 1506 via a magnetic coupling and interface. The magneticcoupling may be configured to mechanically separate the cradle 1516 fromthe load cell 1506, thereby reducing or preventing mechanical forcesfrom continuing to be applied to the flexure beams and/or load cell1506. In at least one example embodiment, as will be described ingreater detail below, upon reaching a predetermined load amount, thecradle 1516 may break a magnetic interconnection force separating thecradle 1516, the plate 1508, and the second component 1514 from theapheresis system 200. Among other things, this magnetic interconnectionmay reduce or prevent damage to the load cell 1506, sensing components,support elements, flexure beams, and/or other mechanical elementsdisposed between cradle 1516 and the load cell 1506.

In at least one example embodiment, the first component 1512 includes afirst magnet 1518 and the second component 1514 includes a second magnet1520. The first magnet 1518 may be coupled to the first component 1512by a first fastener 1522A. The second magnet 1520 may be coupled to thesecond component 1514 by a second fastener 1522B. As will be describedin greater detail below, the load cell 1506 may be coupled to thebracket 1510 by one or more third fasteners 1522C. The first component1512 may be coupled to the load cell 1506 by one or more fourthfasteners 1522D. The mount plate 1508 may be coupled to bracket 1510 byone or more fifth fasteners 1522E. The second component 1514 may becoupled to the cradle 1516 by one or more sixth fasteners 1522F. In atleast one example embodiment, the fasteners 1522A, 1522B, 1522C, 1522D,1522E, 1522F may be independently selected from flat head screws, sockethead cap screws, hex head screws, bolts, and/or the like.

FIG. 15C is a top perspective view of a mount plate of the load cellassembly of FIG. 15A according to at least one example embodiment. FIG.15D is a bottom perspective view of the mount plate of FIG. 15Caccording to at least one example embodiment.

In at least one example embodiment, as shown in FIGS. 15C-15D, the mountplate 1508 includes a substantially planar body 1524 having a first side1526A and a second side 1526B. The planar body 1524 may define asubstantially rectangular perimeter (e.g., a rectangle having roundedcorners).

In at least one example embodiment, the planar body 1524 defines one ormore first apertures 1528 (e.g., four apertures 1528, as shown).Fasteners (not shown) may extend through the first apertures 1528 tocouple the load cell assembly 1500 (shown in FIGS. 15A-15B) to theapheresis system 200 (shown in FIG. 1A) via the mount plate 1508. In atleast one example embodiment, the bottle tray load cell assembly 1500may be completely removed from the apheresis system 200 via removal ofthe fasteners. Among other things, this feature allows quick replacementand/or serviceability of the bottle tray load cell assembly 1500 and/orany component of the bottle tray load cell assembly 1500, as will bedescribed in greater detail below in the discussion accompanying FIG.18A.

In at least one example embodiment, a first flange 1530 extends from theplanar body 1524 on the first side 1526A. The first flange 1530 maydefine a rectangular shape. In at least one example embodiment, themount plate 1508 includes a gasket 1532 (shown in FIG. 15D) on the firstside 1526A. The gasket 1532 may be adjacent to the first flange 1530.When the load cell assembly 1500 (shown in FIGS. 15A-15B) is coupled tothe apheresis system 200 (shown in FIG. 1A), the gasket 1532 is betweenthe planar body 1524 of the plate 1508 and the housing 204 (shown inFIG. 2A). In at least one example embodiment, the gasket 1532 may be orinclude an O-ring, a flat seal gasket, or another compliant sealingmember. Additionally or alternatively, the gasket 1532 may be or includean electromagnetic interference (EMI) shielding gasket (e.g., metalgasket, spring, metalized gasket, and/or the like).

In at least one example embodiment, the planar body 1524 defines asecond aperture 1534. The second aperture 1534 may be a centralaperture. In at least one example embodiment, a second flange 1536 mayextend from the second side 1526B of the planar body 1524. The secondflange 1536 may be a circular flange. The second flange 1536 may extendaround the second aperture 1534. In at least one example embodiment, aportion of the second component 1514 (shown in FIGS. 15A-15B) extendsthrough the second aperture 1534. The second component 1514 may beconfigured to translate along the longitudinal axis 1517 as thedeflection portion (shown in FIGS. 15A-15B) of the load cell assembly1500 deflects. In at least one example embodiment, an amount of thedeflection may be very small, such as less than or equal to about 0.05inches (e.g., less than or equal to about 0.01 inches, or less than orequal to about 0.005 inches).

FIG. 15E is a perspective view of a bracket of the load cell assembly ofFIG. 15A according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 15E, the bracket1510 includes a wall 1538 and a third flange 1540. The third flange 1540may include a first flange portion 1540A and a second flange portion1540B. The first and second flange portions 1540A, 1540B may be spacedapart from one another. The first and second flange portions 1540A,1540B may include respective upper surfaces 1541A, 1541B. The uppersurfaces 1541A, 1541B may be coplanar.

In at least one example embodiment, the wall 1538 defines a receptacle1542. The receptacle 1542 may define a substantially rectangular shape.The receptacle 1542 may receive at least a portion of the load interfaceplate 1512 and/or at least a portion of the overload support bar 1514,as shown in FIG. 15I.

The wall 1538 may further define a depression 1543. The depression 1543may define a semi-cylindrical shape. The depression 1543 may extendbetween the receptacle 1542 and an upper surface 1544 of the wall 1538.The depression may receive at least a portion of the overload supportbar 1514, as shown in FIG. 15I.

In at least one example embodiment, the bracket 1510 may further includegussets 1546 extending between the wall 1538 and the third flange 1540.In at least one example embodiment, the wall 1538, the third flange1540, and the gussets 1546 may cooperate to define an interior bracketregion 1547. As will be described in greater detail below, in at leastone example embodiment, the load cell 1506, the first component 1512,and a portion of the second component 1514 may be in the interiorbracket region 1547. Accordingly, when the mount plate 1508 is attachedto the housing 204 of the apheresis system 200 (shown in FIG. 2A), thebracket 1510 may be inside a guarded portion of the apheresis system 200(e.g., protecting the load cell 1506 and/or other components of the loadcell assembly 1500 from damage, tampering, and/or an environment outsideof the apheresis system 200, etc.).

In at least one example embodiment, the bracket 1510 is attached to themount plate 1508. In the example embodiment shown, the bracket 1510 isattached to the first side 1526A of the mount plate 1508. The uppersurface 1544 of the wall 1538 of the bracket 1510 may define one or morethird apertures 1550. The fifth fasteners 1522E may extend through thethird apertures 1550 and the plate 1508 to couple the bracket 1510 tothe mount plate 1508. The second flange portion 1540B may define one ormore fourth apertures 1551. In at least the example embodiment shown,the third fasteners 1522C may extend through the fourth apertures 1551to couple the load cell 1506 (shown in FIGS. 15A-15B) to the bracket1510, as will be described in greater detail below.

FIG. 15F is a perspective view of a load cell of the load cell assemblyof FIG. 15A according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 15F, the load cell1506 includes a fixed end 1552 (or fixed side) and a free end 1554 (orfree side or load deflection side). As shown in FIG. 15A, the fixed end1552 is fixed to the bracket 1510. Specifically, the fixed end 1552 ofthe load cell 1506 may be in contact with the second flange portion1540B. In at least one example embodiment, the fixed end 1552 of theload cell 1506 may be in direct contact with the second flange portion1540B. The load cell 1506 may be at least partially within the interiorbracket region 1547 of the bracket 1510.

In at least one example embodiment, the free end 1554 of the load cell1506 is spaced apart from at least a portion of the bracket 1510, suchas the first flange portion 1540A, to define a deflection region 1556(also shown in FIGS. 15A and 15I). The free end 1554 of the load cell1506 load cell 1506 is configured to move within the deflection region1556 in response to the application of a force or load in a firstdirection 1558. The first direction 1558 may be substantially parallelto the central axis 1517.

In at least one example embodiment, the load cell 1506 is aflexure-based load cell. As the free end 1554 moves or translatesrelative to the fixed end 1552, the load cell 1506 may determine aforce, weight, or load associated with the measured deflection. Whilethe load cell 1506 may be capable of receiving forces receivedperpendicular to a flexure member of the load cell 1506 (e.g., in thefirst direction 1558), the load cell 1506 may be sensitive torotational, twisting, or parallel forces received. Examples of the loadcell 1506 include, but are not limited to, a shear beam load cell, anS-beam load cell, a single point load cell, a dual shear beam load cell,a bending beam load cell, a canister load cell, a strain gauge, aflexure load cell, and/or combinations thereof.

Returning to FIGS. 15A-15B, in at least one example embodiment, the loadcell assembly 1500 includes a magnetic coupling between the loadinterface plate 1512 and the overload support bar 1514. In at least theexample embodiment shown, the load interface plate 1512 includes thefirst magnet 1518 and the overload support bar 1514 includes the secondmagnet 1520. The magnets 1518, 1520 may be arranged such that oppositepoles are facing one another when the overload support bar 1514 isengaged with the load interface plate 1512, as shown in FIG. 15I. Thisarrangement causes a magnetic force between the magnets 1518, 1520 tomaintain the overload support bar 1514 in an engaged state with the loadinterface plate 1512.

FIG. 15G is a perspective view of a load interface plate of the loadsupport assembly of FIG. 15A according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 15G, the loadinterface plate 1512 includes an interface body or first cam body 1560and an extension or mount 1562. The load interface plate 1512 may definea first or load cell side 1564A and a second or interface side 1564B.The first cam body 1560 may define a first recess or depression 1566.The load interface axis 1517A may be aligned with the central axis 1517(shown in FIG. 15A) when the load cell assembly 1500 (shown in FIG. 15A)is assembled. The first magnet 1518 may be at least partially in thefirst recess 1566. A load interface axis 1517A may extend through acenter of the first recess 1566. The first magnet 1518 (shown in FIG.15B) may be glued, pinned, crimped, or otherwise fastened within firstrecess 1566. In at least the example embodiment shown, the first magnet1518 may be attached to the overload support bar 1514 via the firstfastener 1522A, such as flat head cap screw. In at least one exampleembodiment, a surface of the first magnet 1518 may be disposed flushwith, or under, a first cam surface 1567 of the overload support bar1514.

In at least one example embodiment, the first cam surface 1567 defines aplurality of valleys 1568. In at least the example embodiment shown, theplurality of valleys 1568 includes a first valley 1568A, a second valley1568B, and a third valley 1568C. the valleys 1568 may be asymmetricallydisposed about the load interface axis 1517A (e.g., having centersdisposed about 90° apart from one another). In at least one exampleembodiment, each of the valleys 1568 may be configured as a dwell orrecess having at least one sloped, chamfered, or tapered side.

In at least one example embodiment, the first cam surface 1677 mayfurther define a first flat portion 1569. In the example embodimentshown, the first flat portion 1569 is between the first valley 1568A andthe third valley 1568C. The first flat portion 1569 may extenduninterrupted between the first valley 1568A and the third valley 1568C.The valleys 1568A, 1568B, 1568C and the first flat portion 1569 may becircumferentially around the first recess 1566.

In at least one example embodiment, the second side 1564B of the firstcam body 1560 may further define a plurality of notches 1570. Each ofthe plurality of notches 1570 may correspond to a respective one of thevalleys 1568. The notches 1570 may be centered within each of therespective valleys 1568.

The extension 1562 may be adjacent to the first cam body 1560. In atleast the example embodiment shown, the extension 1562 defines asubstantially rectangular cross section. The extension 1562 may defineone or more fourth apertures 1571. The fourth apertures 1571 may receivefourth fasteners 1522D to couple the load interface plate 1512 to theload cell 1506 (shown in FIG. 15B).

FIG. 15H is a perspective view of an overload support bar of the loadcell assembly of FIG. 15A according to at least one example embodiment.

Referring to FIG. 15H, in at least one example embodiment, the overloadsupport bar 1514 includes a mandrel 1572 extending a length along alongitudinal or support bar axis 1517B (e.g., coinciding with axis 1517of FIG. 15A) from a first end 1573A to a second end 1573B. In at leastone example embodiment, the overload support bar 1514 includes a secondcam body 1574 at the first end 1573A and a coupling portion 1775 at thefirst end 1573A.

In at least one example embodiment, the coupling portion 1575 has alarger diameter than that of the mandrel 1572. The coupling portion 1575may define a receptacle, such as a fifth aperture 1575A. The fifthaperture 1575A may cooperate with the sixth fastener 1522F to couple thecradle 1516 (shown in FIG. 15A) the overload support bar 1514.

In at least one example embodiment, the second cam body 1574 issubstantially cylindrical. The second cam body 1574 may define a secondrecess or depression 1576. The support bar axis 1517B may extend througha center of the second recess 1576. The support bar axis 1517B may bealigned with the central axis 1517 when the load cell assembly 1500(shown in FIG. 15A) is assembled. The second magnet 1520 may be at leastpartially in the second recess 1576. The second magnet 1520 (shown inFIG. 15B) may be glued, pinned, crimped, or otherwise fastened withinsecond recess 1576. In at least the example embodiment shown, the magnetsecond 1520 may be attached to the overload support bar 1514 via thesecond fastener 1522B, such as a flat head cap screw. In at least oneexample embodiment, a surface of the second magnet 1520 may be disposedflush with, or under, a second cam surface 1577 of the overload supportbar 1514.

In at least one example embodiment, second cam surface 1577 defines aplurality of lobes 1578. In at least the example embodiment shown, theplurality of lobes 1578 includes a first lobe 1578A, a second lobe1578B, and a third lobe 1578C. the lobes 1578 may be asymmetricallydisposed about the support bar axis 1517B (e.g., having centers disposedabout 90° apart from one another). In at least one example embodiment,each of the lobes 1578 may be configured as a protrusion having at leastone sloped, or tapered, side extending from a tip of the protrusion.

In at least one example embodiment, the second cam surface 1577 of thesecond cam body 1574 may further define a second flat portion 1579. Inthe example embodiment shown, the second flat portion 1579 is betweenthe first lobe 1578A and the third lobe 1578C. The second flat portion1579 may extend uninterrupted between the first lobe 1578A and the thirdlobe 1578C. The lobes 1578 and the second flat portion 1579 may becircumferentially around the second recess 1576.

In at least one example embodiment, a benefit of the asymmetricalarrangement of lobes 1578 and valleys 1568 (shown in FIG. 15G) is thatthe overload support bar 1514 may engage with the load interface plate1512 in only one orientation (e.g., preventing improper mounting of theplasma collection cradle 1516 to the apheresis system 200, etc.). In atleast one example embodiment, among other things, this asymmetricalarrangement can ensure that plasma collection cradle 1516 is alwaysmounted in substantially the same orientation with the apheresis system200.

In at least one example embodiment, with reference to FIGS. 15G-15H, thearrangement of valleys 1568 (FIG. 15G) may provide at least one matingsurface at each location of the valleys 1568 that is configured tocontact a corresponding surface of the lobes 1578 (FIG. 15H). When theoverload support bar 1514 is engaged with the load interface plate 1512(e.g., in an engaged state), the first cam lobe 1578A may align with andbe within first valley 1568A, the second lobe 1578B may align with andbe within the second valley 1568B, and the third lobe 1578C may alignwith and be within the third valley 1578C. In at least one exampleembodiment, the first cam surface 1567 may be in continuous anduninterrupted contact with the second cam surface 1577.

In at least one example embodiment, when the overload support bar 1514is caused to tilt, twist, or rotate relative to the load interface plate1512 (e.g., via an external force applied to the plasma collectioncradle 1516, shown in FIG. 15A, and/or a plasma collection bottle in theplasma collection cradle 1516, etc.), at least a portion of the secondcam surface 1577 may be disengaged from (e.g., not directly contacting)the first cam surface 1567. In at least this example embodiment, as theoverload support bar 1514 rotates about the axis 1517B, one or more ofthe plurality of lobes 1578 may be caused to contact the first flatportion 1569 of the load interface plate 1512.

FIG. 15I is a partial sectional view of the load cell assembly of FIG.15A in an engaged state according to at least one example embodiment.FIG. 15J is a partial sectional view of the load cell assembly of FIG.15A in a disengaged state, with a portion of a first magnet cut away,according to at least one example embodiment.

In at least one example embodiment, as shown FIGS. 15I-15J, each of themagnets 1518, 1520 has a first pole side 1580A (e.g., a north pole) anda second pole side 1580BB (e.g., a south pole). The first pole side1580A has a first polarity and the second pole side 180B has a secondpolarity that is opposite the first polarity. The magnets 1518, 1520 arearranged respectively such that opposite poles (i.e., poles havingopposite polarity) are facing one another. In the example embodimentshown, the first magnet 1518 is in the first recess 1566 of the loadinterface plate 1512 such that the first pole side 1580A of the firstmagnet 1518 is facing the overload support bar 1514. The second magnet1520 is in the second recess 1576 of the overload support bar 1514 suchthat the second pole side 1580B of the second magnet 1520 is facing theload interface plate 1512. In at least one other example embodiment, aload cell assembly may include a single magnet disposed in a loadinterface plate or an overload support bar with a magneticallyattractive metal (e.g., iron, steel, etc.) disposed in the other of theload interface plate or the overload support bar.

The bottle tray load cell assembly 1500 may be capable of providingoverload protection for the load cell 1506 and/or other components bythe overload support bar 1514 moving between the engaged state shown inFIG. 15I to the disengaged state shown in FIG. 15J when a predeterminedmovement and/or force is received by the overload support bar 1514. Themovement and/or force may correspond to a rotation about the centralaxis 1517 in the rotation direction 1582, a moment about the axis 1517,a moment about the y-axis shown, a moment about the x-axis shown, and/orcombinations thereof. Among other things, the ability to disengage theoverload support bar 1514 from the load interface plate 1512 preventsnonlinear forces (e.g., forces that are not acting along the z-axisalone providing a weight vector, etc.) from damaging the load cell 1506and/or the components of the bottle tray load cell assembly 1500.

In at least one example embodiment, as shown in FIG. 15J, a force isreceived in first rotation direction 1582A causing the overload supportbar 1514 to rotate counterclockwise relative to the load interface plate1512. This force may be caused by an accidental knocking and/ortwisting, of the cradle 1516 causing the overload support bar 1514 torotate about the axis 1517. As the overload support bar 1514 rotates,the lobes 1578 may travel along the sloped, or tapered, sides of thevalleys 1568, raising the overload support bar 1514 relative to the loadinterface plate 1512, and causing the overload support bar 1514 to atleast partially separate from the load interface plate 1512. In at leastone example embodiment, in a fully disengaged state, the overloadsupport bar 1514 is separated from the load interface plate 1512 by aseparation offset distance 1583. In this position, the lobes 1578 may bein contact with the first flat portion 1569 of the load interface plate1512 and removed or disengaged from the valleys 1568.

When the overload support bar 1514 separates from the load interfaceplate 1512, a separation space 1584 may be defined between the overloadsupport bar 1514 and the load interface plate 1512. This separationspace 1584 may cause enough of a gap between the first and secondmagnets 1518, 1520 such that continued rotational forces applied to theoverload support bar 1514 do not exert a specific force (e.g., twisting,rotational, and/or moment, etc.) to the load interface plate 1512. In atleast one example embodiment, the magnetic force between the magnets1518, 1520 when in the disengaged state (e.g., due in part to theseparation offset distance 1583) is less than the magnetic force betweenthe magnets 1518, 1520 when in the engaged state (shown in FIG. 15I).Accordingly, the load cell 1506 is protected from any continuedrotational or moment forces. To reset the bottle tray load cell assembly1500, the overload support bar 1514 may be rotated until the lobes 1578line up with the valleys 1568, the overload support bar 1514 movestoward the load interface plate 1512, and the separation offset distance1583 is reduced and/or closed.

FIG. 15K is a side elevation view of a cradle of the load cell assemblyof FIG. 15A according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 15K, the cradle1516 includes a wall 1586 at least partially defining a vessel region1587. The wall 1586 may be partially cylindrical. A cap 1588 may becoupled to the wall 1586 to facilitate alignment and/or retention of avessel within the vessel region 1587. In at least one exampleembodiment, the cap 1588 facilitates proper removal of the of a vessel(see, e.g., vessel 1598 of FIG. 15M) from the cradle 1516 by lifting aport end or top of a vessel prior to a bottom of the vessel, therebyreducing or preventing leaks of vessel contents from a vent port of thevessel.

The wall 1586 may extend between a first end 1586A and a second end1586B. In at least one example embodiment, the second end 1586B of thewall 1586 includes a pair of alignment surfaces 1589. An alignment angle1590 may be defined between the alignment surfaces 1589. In at least oneexample embodiment, the alignment angle 1590 is greater than or equal toabout 90° (e.g., greater than or equal to about 100°, greater than orequal to about 110°, greater than or equal to about 120°, greater thanor equal to about 130°, greater than or equal to about 140°, or greaterthan or equal to about 150°). The alignment angle 1590 may be less thanor equal to about 160° (e.g., less than or equal to about 150°, lessthan or equal to about 140°, less than or equal to about 130°, less thanor equal to about 120°, less than or equal to about 110°, or less thanor equal to about 100°). The alignment surfaces 1589 may cooperate atleast partially define an alignment region 1591. In at least one exampleembodiment, the wall 1586 further defines a slot 1592 between thealignment surfaces 1589. The alignment surfaces 1589 and/or the slot1592 may, in at least one example embodiment, facilitate properalignment of a vessel within the cradle 1516, as will be described ingreater detail below.

In at least one example embodiment, the wall 1586 defines one or morereceptacles 1586C. The receptacles 1586C may be configured to receive atleast a portion of a calibration weight. In at least the exampleembodiment shown, the receptacles 1586C are sized and shaped to receivea bottom portion of a cylindrical calibration weight. When thecylindrical calibration weight is at least partially within thereceptacles 1586C, a longitudinal axis of the cylindrical calibrationweight is substantially parallel to the central axis 1517 (shown in FIG.15A) of the load cell assembly 1500 (shown in FIG. 15A).

FIG. 15L is a front elevation view of the cradle of FIG. 15K accordingto at least one example embodiment.

In at least one example embodiment, as shown in FIG. 15L, the cradle1516 may be configured to retain a vessel in a desired orientation. Thecradle 1516 may define a vessel angle 1594 between a bottom of the wall1586 and a horizontal plane 1595 (i.e., a plane that is perpendicular tothe direction of gravity). In at least one example embodiment, the anglemay be greater than about 0° (e.g., greater than or equal to about 1°,greater than or equal to about 2°, greater than or equal to about 3°,greater than or equal to about 5°, or greater than or equal to about)10°. The vessel angle 1594 may be less than or equal to about 45° (e.g.,less than or equal to about 40°, less than or equal to about 35°, lessthan or equal to about 30°, less than or equal to about 25°, less thanor equal to about 20°, less than or equal to about 15°, less than orequal to about 10°, less than or equal to about 8°, or less than orequal to about 5°).

FIG. 15M is perspective view of a vessel in the cradle of FIG. 15Kaccording to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 15M, the cradle1516 is configured to retain a vessel in a desired orientation. In atleast the example embodiment shown, the vessel is a bottle 1598. Thebottle 1598 may be similar to or the same as the bottle 1900 of FIG.19A. The bottle 1598 may include a cap 1598A. The cap 1598A may includea protrusion 1598B including a pair of vessel alignment surfaces 1598C,a pair of side surfaces 1598D, and an opposing surface 1598E. The cap1598A may further include a fluid port 1598F and a vent port 1598G. Inat least one example embodiment, when the bottle 1598 is installed inthe cradle 1516 for use, a vent cap 1598H may be removed from the ventport 1598G and a tube and connector may be connected to the fluid port1598F (see, e.g., FIGS. 19I, 19J).

In at least one example embodiment, when the bottle 1598 is properlyoriented in the cradle 1516, the protrusion 1598B is at least partiallywithin the alignment region 1591. The alignment surfaces 1589 of thecradle 1516 engage (e.g., are in direct contact with) the vesselalignment surfaces 1598C and the fluid port 1598F is at least partiallywithin the slot 1592. Accordingly, the vent port 1598G is oriented at ahigher location than the fluid port 1598F, at a location above apredetermined (or alternatively, desired) fluid level. In thisorientation, filling capacity of the bottle 1598 may be increased ormaximized compared to other orientations since placement of the ventport 1598G at the top allows greater fill volume without contentsoverflowing through the vent port 1598G. Moreover, this orientation mayreduce or minimize residual volume such that fluid can be drawn back outof the bottle 1598 without drawing air. The vessel 1598 is oriented atthe vessel angle 1594. The vessel angle 1594 may be selected to balanceresidual needs with high fill volume.

In at least one example embodiment, as will be discussed in greaterdetail below in the discussion accompanying FIG. 26J, the bottle 1598and/or cap 1598A may be sized and shaped to ensure proper placement ofthe cap 1598A of the bottle 1598 below a bottom of the bottle 1598 inthe cradle 1516. That is, the cap 1598A may be oriented toward the firstend wall 1586A and the bottom of the bottle 1598 may be oriented towardthe second end wall 1586B.

In at least one example embodiment, the bottle 1598 and cradle 1516include one or more features to facilitate visual identification ofimproper loading. A user may readily identify when the bottle 1598 isdisposed at an angle other than the vessel angle 1594 (FIG. 15K), thatis, when a longitudinal axis of the bottle 1598 is not parallel to thecradle 1516. Additionally or alternatively, a user may readily identifywhen the vessel alignment surfaces 1598C are not fully seated on thealignment surfaces 1589 of the cradle 1516. Additionally oralternatively, a user may identify when the ports 1598F, 1598G are notvertically aligned, with the fluid port 1598F within the slot 1592G.Additionally or alternatively, a user may identify when a label 1598I ofthe bottle 1598 is not visible, facing upward, and/or substantiallycentered within the cradle 1516.

In contrast, in at least one example embodiment, when the bottle 1598 isin an improper orientation within the cradle 1516, the opposing surfaceengages one or both of the alignment surfaces 1589, thereby preventingthe protrusion 1598B from being in the alignment region 1591. In theimproper orientation, fluid may be pushed from the bottle 1598 throughthe vent port 1598G, which may be below the fluid level in the improperorientation. When flow is reversed, air would be drawn from the bottle1598 rather than the intended fluid.

Exemplary aspects are directed to a bottle tray load cell assembly,comprising: a support bracket; a load cell comprising a fixed side and aload deflection side offset from the fixed side, wherein the fixed sideof the load cell is attached to the support bracket; an interface plateattached to the load deflection side of the load cell, the interfaceplate comprising: a body; a first magnet recess disposed in the body;and a plurality of cam lobe valleys at least partially around the firstmagnet recess, wherein the plurality of cam lobe valleys interrupt afirst contact surface of the body; a support bar comprising: a mandrelextending a length along a longitudinal axis from a first end of themandrel to a second end of the mandrel; a cam body disposed at thesecond end of the mandrel; a second magnet recess disposed in the cambody; and a plurality of cam lobes extending from the cam body, theplurality of cam lobes arranged at least partially around the secondmagnet recess; wherein the support bar is moveable between an engagedstate with the interface plate and a disengaged state from the interfaceplate, wherein, in the engaged state, the plurality of cam lobes aredisposed in contact the plurality of cam lobe valleys, and wherein, inthe disengaged state, the plurality of cam lobes are disposed out ofcontact with the plurality of cam lobe valleys and are in contact withthe first contact surface of the body.

Any one or more of the above aspects further comprising: a first magnetdisposed in the first magnet recess, the first magnet comprising afirst-magnet pole having a first polarity, the first-magnet pole facingaway from the body of the interface plate; and a second magnet disposedin the second magnet recess, the second magnet comprising asecond-magnet pole having a second polarity, the second-magnet polefacing away from the cam body of the support bar, wherein thefirst-magnet pole faces the second-magnet pole, and wherein the firstpolarity is opposite the second polarity. Any one or more of the aboveaspects include wherein the support bar is maintained in the engagedstate with the interface plate by a magnetic force between the firstmagnet and the second magnet, and wherein a first movement of thesupport bar relative to the interface plate causes the support bar toseparate a distance from the interface plate and move the support barfrom the engaged state with the interface plate to the disengaged statefrom the interface plate. Any one or more of the above aspects includewherein the first movement comprises a rotational movement about thelongitudinal axis, and wherein the rotational movement comprises a forcegreater than the magnetic force. Any one or more of the above aspectsfurther comprising: a collection cradle fixedly attached to the firstend of the mandrel. Any one or more of the above aspects include whereinthe load deflection side moves independently of the support bracket. Anyone or more of the above aspects include wherein the plurality of camlobe valleys comprise at least three cam lobe valleys arrangedasymmetrically around an axis running through a center of the firstmagnet recess, and wherein the plurality of cam lobes comprises at leastthree cam lobes. Any one or more of the above aspects include whereinthe at least three cam lobe engage with the at least three cam lobevalleys in a single rotational orientation about the axis runningthrough the center of the first magnet recess. Any one or more of theabove aspects include wherein the support bar rotates about thelongitudinal axis in the disengaged state without imparting rotationalforce to the load cell via the interface plate.

Exemplary aspects are directed to a method of disengaging a supportmember from a weigh scale assembly, comprising: providing a load cellassembly, comprising: a support bracket; a load cell comprising a fixedside and a load deflection side offset from the fixed side, wherein thefixed side of the load cell is attached to the support bracket; aninterface plate attached to the load deflection side of the load cell,the interface plate comprising: a body; a first magnet recess disposedin the body; and a plurality of cam lobe valleys at least partiallyaround the first magnet recess, wherein the plurality of cam lobevalleys interrupt a first contact surface of the body; a support barcomprising: a mandrel extending a length along a longitudinal axis froma first end of the mandrel to a second end of the mandrel; a cam bodydisposed at the second end of the mandrel; a second magnet recessdisposed in the cam body; and a plurality of cam lobes extending fromthe cam body, the plurality of cam lobes arranged at least partiallyaround the second magnet recess; wherein the support bar is moveablebetween an engaged state with the interface plate and a disengaged statefrom the interface plate, wherein, in the engaged state, the pluralityof cam lobes are disposed in contact the plurality of cam lobe valleys,and wherein, in the disengaged state, the plurality of cam lobes aredisposed out of contact with the plurality of cam lobe valleys and arein contact with the first contact surface of the body; positioning thesupport bar in the engaged state with the interface plate such that theplurality of cam lobes are in contact with the plurality of cam lobevalleys; receiving a movement force at the support bar causing thesupport bar to move from the engaged state to the disengaged state,wherein the movement force comprises a rotational force about thelongitudinal axis; and moving, while in the disengaged state, thesupport bar independently of the interface plate and without imparting aspecific rotational force to the interface plate and the load cell.

Example Communication Methods of the Apheresis System

In at least one example embodiment, the apheresis system 200, asdescribed herein, may comprise one or more computer systems, such as thecomputer system 1627. The processor 1630 of the computer system 1627 maybe configured to execute one or more of the processes and methodsdescribed herein. The processor 1630 may execute software. For example,the software may include firmware, applications, and/or operatingsystems which may manage execution of the apheresis system 200.

Software, including firmware, applications, operating systems, and otherprogrammable features of the apheresis system 200, may be updated fromtime to time to ensure the apheresis system 200 is operating as needed.

The apheresis system 200 may include an application that, among otherthings, performs fleet management and allows customers to installsoftware for bulk groups of devices. Software systems implemented by theapheresis system 200 may be configured to generate and/or compile devicelogs (D-logs) to send to a cloud storage location. D-logs may be usedfor predictive analytics or other purposes. Each apheresis system 200may be in communication with a remote system server 1621 (e.g., over acommunications network 1618, in the cloud, etc.), as illustrated in FIG.16B. During startup, each apheresis system 200 may communicateinformation about the software, including a firmware version, error logsencountered, etc., to the server 1621 using a method such as illustratedin FIG. 16A.

The system server 1621 may be configured to determine whether thesoftware and/or the firmware version of the apheresis system 200 needsupdating (e.g., is out of date, etc.). In at least one exampleembodiment, the system server 1621 may force a software and/or afirmware update automatically or give a user an option to update thesoftware and/or the firmware. In at least one example embodiment, anexternal device may be connected to the apheresis system 200 to updatethe software. For example, the external device may be a computer orlaptop configured to be connected to the apheresis system 200 and toupdate the software of the apheresis system 200. In any event, if thesoftware for an apheresis system 200 is not updated, the apheresissystem 200 may be prevented from operating. This prevention may be basedon a lock signal sent by the system server 1621 or by the apheresissystem 200 not receiving an unlock signal from the system server 1621that allows operation.

The method of FIG. 16A may begin at 1600 in which the apheresis system200 may be in an off or unused state. At 1603, the apheresis system 200may be powered and may run through a power-up process. A computer system1627, such as illustrated in FIG. 16D, may be configured to detect astartup of the apheresis system 200 or may be configured toautomatically perform a process such as described herein upon startup.

In response to detecting start up, the computer system 1627 may transmitdata to a server 1621 via a connection to a network 1618, as illustratedin FIG. 16B. The data transmitted to the server 1621 may comprise one ormore of a data log, a firmware version identifier, and an error log.

At 1609, the apheresis system 200 may receive a response from the server1621 in response to the data transmitted to the server 1621. The server1621 may be configured to determine, based on the data, whether thesoftware of the apheresis system 200 is a current and/or up-to-dateversion. If the software is out-of-date or is not the current version,the server 1621 may send a lockout signal or other type of data packetinstructing the apheresis system 200 to require a software update beforebeing used. In at least one example embodiment, an apheresis system 200may not be usable until a positive confirmation that the software is upto date is received from the server 1621 via the network connection1618. In this way, the risks associated with using an outdated apheresis200 system may be avoided. For example, at 1612, usage of the apheresissystem 200 may be prevented based on the response received from theserver.

In at least one example embodiment, if the server 1621 determines thesoftware is out-of-date, the server may send, as part of its response,one or more files for updating the software. Additionally oralternatively, the software of the apheresis system 200 may beautomatically updated. For example, the software update may beautomatically initiated after receiving the one or more files forupdating the software from the server. In at least one exampleembodiment, the apheresis system 200 may enable a user to manuallyupdate the system once the one or more files for updating the softwareare received. For example, the user may manually initiate the softwareupdate after receiving the one or more files. Once the software has beenupdated, the apheresis system 200 may be configured to unlock and allowusage of the system.

In at least one example embodiment, the method illustrated in FIG. 16Amay further comprise, after preventing usage of the apheresis machine,determining whether an unlock requirement has been met. For example, theunlock requirement may include properly updating the software. Inresponse to determining the unlock requirement has been met, theapheresis system 200 may enable usage.

In at least one example embodiment, a message may be displayed on agraphical user interface 1624 of the apheresis system 200, asillustrated in FIG. 16C. The message may inform a user as to whether theapheresis system 200 is locked due to out-of-date software and mayenable a user to manually install an update to the software as needed.In at least one example embodiment, the user may manually initiateinstallation of the update to the software using the graphical userinterface (GUI) 1624. In other embodiments, the user may connect anexternal device including the update to the software to the apheresissystem 200 to initiate and install the software update.

At least one example embodiment includes a method comprising: detectinga startup of an apheresis machine; in response to detecting start up,transmitting data to server; receiving, in response to data, a responsefrom the server; and based on the response from the server, preventingusage of apheresis machine.

Aspects of the above embodiment include wherein the data transmitted tothe server comprises one or more of a data log, a firmware versionidentifier, and an error log. Aspects of the above embodiment includewherein the response comprises a lockout signal. Aspects of the aboveembodiment include wherein the response comprises a firmware update.Aspects of the above embodiment include wherein the firmware update isinstalled automatically. Aspects of the above embodiment include whereinthe apheresis machine ceases to prevent usage following installation ofthe firmware update. Aspects of the above embodiment include wherein thefirmware update is installed manually by a user. Aspects of the aboveembodiment include, based on the response from the server, displaying amessage on a graphical user interface. Aspects of the above embodimentinclude wherein the graphical user interface enables a user to begin afirmware installation. Aspects of the above embodiment include, afterpreventing usage of the apheresis machine, determining an unlockrequirement has been met; and, in response to determining the unlockrequirement has been met, enabling use of the apheresis machine. Aspectsof the above embodiment include wherein the unlock requirement isassociated with an updated firmware.

Example Methods and Processes Providing Donation Process Feedback

The apheresis system 200 may include one or more interface elements(e.g., display devices, LEDs, alarms, etc.) that provide indications toa user and/or the donor 102 regarding information about the donationprocess. In one example, these interfaces may indicate to the donor 102that the donor 102 should squeeze (e.g., when pressure or flow fallsbelow a predetermined threshold, etc.). Additionally or alternatively,the interface elements may indicate to the donor 102 how far in thedonation process they are. In any event, this feedback may be providedin audible and/or visual output by the apheresis system 200 (e.g., viaone or more speakers, display devices, LEDs, etc.). In at least oneexample embodiment, LEDs may be arranged on the side of the apheresissystem 200 that provides this feedback to the donor 102.

The method illustrated by the flowchart of FIG. 17A may begin at 1700.At the beginning of the method, an apheresis system, such as theapheresis system 200, may be powered on and connected to a donor, suchas the donor 102.

At 1703, a computer system of the apheresis system 200 may detect abeginning of a donation process. In at least one example embodiment, nodetection per se may be required, but instead the method illustrated inFIG. 17A may be performed automatically as part of the donation process.For example, detecting the beginning of a donation process may compriseinitiating the donation process. In at least one example embodiment,detecting the beginning of the donation process may comprise detecting aflow of fluid, for example, by using one or more sensors, such as thefluid sensor 316.

At 1706, once the donation process begins, the apheresis system mayprovide an output which is noticeable by the donor 102. For example, theoutput may be a light, sound, GUI display, etc. The output may beprovided in view of the donor 102. In at least one example embodiment, aside of the apheresis system 200 may include an output 1724, asillustrated in FIG. 17B. For example, the output 1724 may comprise aseries of lights, such as light emitting diodes (LEDs). While displayedas being on a particular side of the apheresis system 200, it should beappreciated that the output 1724 may be on any side of the apheresissystem 200 and may be within a range of the donor 102 such that theoutput may be one or more of viewed and heard by the donor 102.

In at least one example embodiment, the output 1724 may be a displaydevice. For example, the output 1724 may illuminate or glow in such away as to visualize to a donor, or other user of the apheresis system,information such as how much time is remaining in the donation process,whether the donor should squeeze her hand to improve a flow of bloodinto the apheresis system, or other information. The output 1724 may beconfigured to illuminate or glow in a pulsing manner, in which a rate ofthe pulses of light may be synchronized with a rate at which the donorshould squeeze her hand to reach an optimal rate of flow.

At 1709, the method may comprise determining a percentage of thedonation process completed and/or remaining. For example, this mayinclude determining an amount of time remaining for the donationprocess. Determining an amount of time remaining may comprise firstdeterminizing an amount of plasma expected to be donated by the donor102. Determining the amount of plasma expected to be donated by thedonor may comprise receiving donor information as part of an initiationprocess. For example, the donor information may be received from adonor's ID card via a reader or scanner, such as the reader 1221described above.

Determining an amount of time remaining may comprise dividing the amountof plasma expected to be donated by a donor by an expected flow rate.For example, if the apheresis system 200 determines there is an expectedone liter of plasma yet to be donated, and that plasma is expected to bedonated at a rate of one liter per minute, the apheresis system 200 maydetermine there is one minute remaining for the donation process.

At 1712, the method may comprise, in response to detecting the amount oftime remaining for the donation process, updating the output.

In at least one example embodiment, updating the output, such as theoutput 1724, may comprise adjusting a number of lights or a percentageof a display illuminated. For example, as illustrated in FIGS. 17C-17E,the output 1724 may comprise five lights, 1727 a-e. Each of the fivelights 1727 a-e may be independently illuminated based on an amount oftime remaining. Further, as discussed above, the lights 1727 a-e may becapable of being pulsed, that is, a brightness of each light may beindependently adjusted so that a pulsing effect may be achieved.

As illustrated in FIG. 17C, each light of the output 1724 may be turnedoff or otherwise not illuminated to illustrate to a donor that thedonation process has just begun. As illustrated in FIG. 17D, a subset ofthe lights 1727 a-e may be illuminated based on an amount of timeremaining as compared to a total time for the donation process. Forexample, if the donation process is sixty percent complete, sixtypercent of the lights may be illuminated. As illustrated in FIG. 17E,every light of the output 1724 may be illuminated to illustrate to adonor that the donation process is or is near complete. In at least oneexample embodiment, a color of the lights 1727 a-e of the output 1724may change upon completion of the donation process.

At 1715, the method may comprise detecting a loss in pressure. Detectinga loss in pressure may comprise detecting that a pressure of a fluid inthe apheresis machine 200 drops below a predetermined threshold. A lossin pressure may be attributed to poor circulation in the donor 102, acollapsed vein, an insufficiently powered pump, or other reasons. Insome cases, the donor 102 may be required to squeeze her hand toincrease the rate of flow into the apheresis system 200. By squeezingher hand at a particular rate, the donor 102 may be enabled to controlthe rate of flow into the apheresis system 200.

At 1718, in response to detecting the loss in pressure, the method maycomprise updating the output 1724. For example, in response to detectinga loss in pressure, the apheresis system 200 may update the output 1724such that the output 1724 instructs the donor 102 to squeeze. Updatingthe output 1724 to instruct the donor to squeeze may comprise flashing.For example, one or more of the lights 1727 a-e may be turned on andoff. In at least one example embodiment, a brightness of one or more ofthe lights 1727 a-e may be pulsed at a particular rate. The rate atwhich the lights are pulsed or flashed may be based on a particular flowrate which needs to be achieved in order to complete the donationprocess.

At 1721, the method may end when the donation is complete. In at leastone example embodiment, ending the method may comprise detecting theending of the donation process. Ending the method may comprise turningoff the output 1724. For example, after detecting and ending of thedonation process, the apheresis system 200 may perform an outputroutine, indicating to the donor 102 that the donation process iscomplete. Such an output routine may comprise one or more of flashingthe lights of the output 1724 in a particular order, changing a color ofthe lights of the output 1724, generating a noise, or making some othernoticeable output, which may indicate to the donor 102 that the donationprocess is complete. After the output routine, the apparatus or systemmay cease making any noise, and may turn off any lights.

In at least one example embodiment, during a donation process, theapheresis system 200 may be configured to detect alarm events and, inresponse, alert a user as to the alarm. For example, during a plasmadonation process, a processor of a computer system or microcontrollerwithin the apheresis system 200 may be configured to detect a factorsuch as temperature, pressure, flow rate, color, weight, input data froma scanner, or other factors. If any of the factors are incorrect, toohigh, too low, etc., the processor may generate a graphical output whichmay alert a user as to the alarm event and/or instruct the user as tohow to resolve the alarm event.

Detecting an alarm event associated with an apheresis system maycomprise monitoring factors such as temperature, pressure, flow rate,color of fluid, weight of plasma received, data received from a scanner,motor control, centrifuge speed, software failure modes, and/or otherfactors relating to the donation process.

Detecting the alarm event may comprise receiving data from one or moresensors such as temperature sensors, pressure sensors, flow ratesensors, color sensors, valve sensors, weight sensors, a scanner, orother device.

The sensors may be placed throughout the apheresis system 200 and may beconfigured to monitor a number of aspects of the donation process, suchas weight of the plasma donation bottle, flow rates and flow pressuresof tubing, speed of the centrifuge, and/or other elements.

The alarm event may be detected when one of the factors crosses athreshold or reaches a particular value. The threshold may be an upperthreshold or a lower threshold or may be a particular amount or a range.In the case of the alarm being related to a color of fluid, for example,the threshold may be a particular color or range of colors.

The threshold may also be related to a time or time range. For example,an alarm event may be detected when data received from a scanner, suchas donor identification data, is out-of-date or expired. In at least oneexample embodiment, the alarm event may be detected when data receivedfrom the scanner indicates one or more of an expired instrument ordevice, an invalid instrument or device, and an incompatible instrumentor device.

In at least one example embodiment, an alarm event may be based on datafrom multiple sensors. For example, an alarm event may occur when bothpressure and temperature cross particular thresholds.

After detecting the alarm, the processor may generate or retrieve agraphical presentation output based on the alarm event detected.

Generating a graphical presentation output may comprise providing textdescribing the alarm event, providing one or more images describing thealarm event, and/or providing other content aimed towards instructing auser as to how to resolve the alarm.

Retrieving a graphical presentation output may comprise pulling frommemory one or more of text describing the alarm event, one or moreimages describing the alarm event, and/or other content aimed towardsinstructing a user as to how to resolve the alarm.

The instructions comprise at least one instruction to move the apheresissystem 200 from an alarm state to an operating state. An instruction tomove the apheresis system 200 from an alarm state to an operating statemay comprise visual aids and/or text informing a user as to what stepsmay be performed which may resolve the issue underlying the alarm event.For example, the instructions may comprise information instructing auser to perform one or more of connect a tube, close a latch, and removea kink from a tube. In at least one example embodiment, the instructionsmay include instructing the user to end the donation process anddisconnect a donor from the apheresis system 200.

After generating and/or retrieving the graphical presentation outputbased on the alarm event detected, the processor may render thegraphical presentation output to a graphical user interface of theapheresis system.

In at least one example embodiment, the processor may additionally, oralternatively to rending the graphical presentation output to a GUI,such as the GUI 1230 shown in FIG. 12B; illuminate one or more lightemitting diodes (LEDs); and/or output an audible sound upon detection ofthe alarm event. The LEDs may be switchable between a plurality ofcolors, such as orange, yellow, red, and cyan. The color of the LEDs maybe selected by the processor to correspond to a type of the alarm eventdetected. In at least one example embodiment, the LEDs may include oneor more lights 2339, as will be discussed below with respect to FIG.22C.

In at least one example embodiment, each color may be associated with adifferent type and/or level of alarm. For example, a type of alarm mayindicate the alarm is associated with a one or more of temperature,pressure, flow rate, color, and weight.

A level of alarm may indicate, for example, a severity or priority ofthe alarm. In at least one example embodiment, different thresholds maybe used to determine whether a particular factor is at a mild or severelevel. For example, if a normal pressure is 10 PSI, a mild level alarmmay be set for pressures under 5 PSI and a severe level alarm may be setfor pressures of zero PSI. In at least one example embodiment, a highseverity alarm may be red. In at least one example embodiment, a mediumpriority alarm may be yellow or orange. In at least one exampleembodiment, a low priority alarm may be green or blue. In at least oneexample embodiment, the light may be off or not illuminated if no alarmevent is presently detected.

In at least one example embodiment, the level of severity or priority ofthe alarm may be indicated by blinking or flashing of the light. Therate at which the light blinks may also indicate the severity of thealarm. For example, a light blinking at a faster rate or tempo may be ofhigher severity and priority and a light blinking at a slower rate ortempo may be of lower priority.

In at least one example embodiment, an audible alert or sound mayindicate the level of severity or priority of the alarm event. Forexample, various sounds, sound patterns, and sound frequencies mayindicate a level of priority. For example, higher frequency sounds mayindicate higher priority alarm events and lower frequency sounds mayindicate lower priority alarm events In at least one example embodiment,the rate at which a sound is made may indicate the level of severity ofthe alarm event. For example, a sound that occurs, such as a beep, morefrequently within a period of time may indicate a higher priority alarmevent.

The color of the alarm may be set based on both the type of alarm aswell as the severity. For example, an alarm relating to temperature maybe a blue light and the brightness or shade of color may be adjustedbased on alarm severity.

In at least one example embodiment, the graphical presentation outputmay comprise a timestamp indicating a time the alarm event occurred.

In at least one example embodiment, the graphical presentation maycomprise a description of the alarm and a list of actions to resolve thealarm.

In at least one example embodiment, the graphical presentation outputmay comprise an illustration associated with the alarm event. Forexample, a photo or illustration may be displayed so that a user may beinstructed how to resolve the alarm state.

In at least one example embodiment, the graphical presentation comprisesGUI elements enabling a user to one or more of reset, continue, and endthe donation process.

In at least one example embodiment, after rendering the graphicalpresentation output, the method may comprise performing a system check.In at least one example embodiment, the system check may be performedcontinuously through the donation process. Performing a system check maycomprise polling data associated with the alarm event to determinewhether the factor causing the alarm event has returned to a normallevel. If the factor causing the alarm event has returned to the normallevel, the alarm may then be resolved and ended. In at least one exampleembodiment, the alarm event may require the donation process to be endedand the donor disconnected from the apheresis system 200. In suchembodiments, the system check may determine that the alarm event may notbe resolved or recoverable and may trigger an alarm and/or provideinstructions to end the donation process and disconnect the donor 102.

For example, if a temperature dropping below a predetermined thresholdcaused the alarm event, performing the system check may comprisedetermining whether the temperature is at or above the predeterminedthreshold.

At least one example embodiment includes a method comprising: detectinga beginning of a donation process; in response to detecting thebeginning of the donation process, providing an output; determining anamount of time remaining for the donation process; in response todetecting the amount of time remaining for the donation process,updating the output; detecting a loss in pressure; in response todetecting the loss in pressure, updating the output; detecting an endingof the donation process; and in response to detecting the ending of thedonation process, updating the output.

Aspects of the above embodiment include wherein the donation process isa plasma donation using an apheresis machine. Aspects of the aboveembodiment include wherein detecting the beginning of the donationprocess comprises detecting a flow of fluid. Aspects of the aboveembodiment include wherein the output is one or more of a light and asound. Aspects of the above embodiment include wherein the output isprovided on a side of an apheresis machine. Aspects of the aboveembodiment include wherein the output is within a range of a donor.Aspects of the above embodiment include wherein the output may be one ormore of viewed and heard by the donor. Aspects of the above embodimentinclude wherein the output is a display device. Aspects of the aboveembodiment include wherein the display device displays a series oflights. Aspects of the above embodiment include wherein the series oflights updates to illustrate to a donor an amount of time remaining inthe donation process. Aspects of the above embodiment include whereinthe series of lights pulses to instruct the donor to squeeze. Aspects ofthe above embodiment include wherein the pulsing of the lights is of atempo associated with a rate at which the donor should squeeze tomaintain pressure. Aspects of the above embodiment include whereindetecting a loss in pressure comprises detecting pressure of a fluid inthe apheresis machine drops below a predetermined threshold. Aspects ofthe above embodiment include, in response to detecting the loss inpressure, updating the output comprises instructing a donor to squeeze.Aspects of the above embodiment include, in response to detecting theending of the donation process, updating the output comprises ceasing anaudible noise or turning off a light.

At least one example embodiment of the present disclosure includes amethod comprising: detecting an alarm event associated with an apheresissystem, retrieving a graphical presentation output based on the alarmevent detected, and rendering the graphical presentation output to agraphical user interface of the apheresis system.

Aspects of the above method include wherein the method is performed byan apheresis system being used to perform a plasma donation process.Aspects of the above method include wherein the alarm event is relatedto one or more of the following factors: temperature; pressure; flowrate; color of fluid; excessive amount of plasma received; and datareceived from a scanner. Aspects of the above method include wherein thealarm event is associated with out-of-date data received from thescanner. Aspects of the above method include wherein the alarm event isdetected when one of the factors crosses a threshold. Aspects of theabove method include wherein detecting the alarm event comprisesreceiving data from one or more sensors. Aspects of the above methodinclude wherein retrieving the graphical presentation output comprisesgenerating the graphical presentation output. Aspects of the abovemethod include wherein the graphical presentation output comprisesinstructions describing the alarm event. Aspects of the above methodinclude wherein the instructions comprise at least one instruction tomove the apheresis system from an alarm state to an operating state.Aspects of the above method include wherein the instructions compriseinstructing a user to one or more of connect a tube, close a latch, andremove a kink from a tube. Aspects of the above method includeilluminating a light emitting diode (LED) upon detection of the alarmevent. Aspects of the above method include wherein a color of the lightemitting diode is selected by the processor to correspond to a type ofthe alarm event detected; wherein the color is selected from orange,yellow, red, and cyan; and wherein the type of the alarm is associatedwith one or more of: temperature, pressure, flow rate, color, andweight. Aspects of the above method include, after rendering thegraphical presentation output, performing a system check. Aspects of theabove method include wherein performing the system check comprisespolling data associated with the alarm event. Aspects of the abovemethod include wherein the graphical presentation output comprises atimestamp indicating a time the alarm event occurred. Aspects of theabove method include wherein the graphical presentation output comprisesan illustration associated with the alarm event. Aspects of the abovemethod include wherein the illustration instructs the user to resolvethe alarm state. Aspects of the above method include wherein thegraphical presentation comprises a description of the alarm and a listof actions to resolve the alarm. Aspects of the above method includewherein the graphical presentation comprises GUI elements enabling auser to one or more of reset, continue, and end the donation process.

Example Modular Serviceability Sled and Interconnections

In at least one example embodiment, an apheresis system (e.g., theapheresis system 200 or the apheresis system 1800) includes one or moresubsystems (e.g., electrical power subassembly, pneumatic controlsubassembly, communications subassembly, pumps 208, 212, 216, bottletray load cell assembly 1500, etc.) that are attached to a sled, ormechanical frame, that is capable of being separated completely from theapheresis system for service, maintenance, and/or replacement. Themodular serviceability sleds may include one or more mechanical and/orelectrical interconnections that can be selectively decoupled from arespective one or more mechanical and/or electrical interconnection ofthe apheresis system. Once decoupled, an entire subsystem on aparticular modular serviceability sled may be removed from the apheresissystem, for example, independently of other subsystems and modularserviceability sleds.

In at least one example embodiment, the modular serviceability sled maybe separated into discrete and/or combination subsystem sleds. Forinstance, one modular serviceability sled may include a plurality ofpneumatic systems (e.g., two or more manifolds, valves, etc.) for theapheresis system, another modular serviceability sled may include aplurality of electrical systems (e.g., two or more processors,controllers, memory devices, power supplies, wiring harnesses,connectors, etc.), and/or other modular serviceability sleds maycomprise electrical and/or mechanical subsystems that are groupedtogether based on predicted and/or historical serviceabilityrequirements.

In at least one example embodiment, one or more of the pumps 208, 212,216 (shown in FIG. 2A) may be quickly replaceable via removing a limitednumber of fasteners (e.g., screws, bolts, nuts, etc.) associated with arespective modular serviceability sled. After the fastener(s) areremoved, the entire respective modular serviceability sled andassociated system (e.g., pump 208, 212, 216) may be removed from theapheresis system without requiring teardown of the apheresis systemand/or the removal of other panels, frames, etc.

Among other things, these modular serviceability sleds may allowcomponents to be quickly separated from the apheresis system andserviced separately from the apheresis system. In at least one exampleembodiment, once a modular serviceability sled has been removed from theapheresis system, a different (e.g., new, refurbished, etc.) modularserviceability sled may be replaced in the apheresis system and theapheresis system may continue to operate (e.g., while the removedmodular serviceability sled is being serviced, returned tomanufacturing, or repaired/reworked). This approach may allow for thesingle-minute exchange of subsystems providing, among other things,enhanced operability and reduced down time for an apheresis system whencompared to the maintenance required for other apheresis systems, whichcould take hours or longer to service.

FIG. 18A is a partially exploded perspective view of an apheresis systemincluding modular serviceability sleds according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 18A, an apheresissystem 1800 includes one or more modular serviceability sleds 1802. Theapheresis system 1800 may be similar to the apheresis system 200 of FIG.1A. In at least the example embodiment shown, the sleds 1802 include afirst sled 1802A, a second sled 1802B, a third sled 1802C, a fourth sled1802D, a fifth sled 1802E, a sixth sled 1802F, a seventh sled 1802G, aneighth sled 1802H, and ninth sleds 1802I (collectively referred to asthe “sleds 1802”). The apheresis system 1800 may further include a baseassembly 1804. The base assembly 1804 may define a plurality ofreceiving spaces 1806. The receiving spaces 1806 may be defined in anysurfaces (or multiple surfaces) of the base assembly 1804, including atop surface, side surfaces, and/or back surfaces, etc. Each of the sleds1802 may be at least partially within one of the receiving spaces 1806.Each of the sleds 1802 may include a modular frame that is configured tobe selectively engaged with the apheresis system, as will be describedin greater detail below.

In at least one example embodiment, the base assembly 1804 includes ahousing 1804A and a frame 1804B. The housing 1804A may comprise plasticand the frame 1804B may comprise metal. In at least one other exampleembodiment, a base assembly may include an integral housing and frame.In at least one example embodiment, the housing 1804A may include slopedor countered regions 1807 at peripheries of some or all of the receivingspaces 1806. The sloped or contoured regions 1807 may be configured todirect fluid away from the sled 1802 (e.g., a gasket 1818 of the sled1802) to reduce or prevent pooling of liquid near the gasket 1818 and/orfacilitate ease of cleaning of the housing 1804A.

In at least one example embodiment, the first modular serviceabilitysled 1802A includes a draw pump. The draw pump may be similar to or thesame as the draw pump 208 of FIG. 2A. The draw pump may be configured tohave an electrical power connection, an electrical communicationconnection, and a pneumatic connection with the base assembly 1804. Thefirst modular serviceability sled 1802A may have an environmental orfluid gasket and a shielding component configured to engage the baseassembly 1804.

In at least one example embodiment, the second modular serviceabilitysled 1802B includes a return pump. The return pump may be similar to orthe same as the return pump 212 of FIG. 2A. The return pump may beconfigured to have an electrical power connection, an electricalcommunication connection, and a pneumatic connection with the baseassembly 1804. The second modular serviceability sled 1802B may have anenvironmental or fluid gasket and a shielding component configured toengage the base assembly 1804.

In at least one example embodiment, the third modular serviceabilitysled 1802C includes an AC pump. The AC pump may be similar to or thesame as the AC pump 216 of FIG. 2A. The AC pump may be configured tohave an electrical power connection and an electrical communicationsconnection with the base assembly 1804. The third modular serviceabilitysled 1802C may have an environmental or fluid gasket and a shieldingcomponent configured to engage the base assembly 1804.

In at least one example embodiment, the fourth sled 1802D includes afluid valve control system. The fluid valve control system may besimilar to or the same as the fluid valve control system 228 of FIG. 2A.The fluid valve control system may be configured to have an electricalpower connection, an electrical communication connection, and apneumatic connection with the base assembly 1804. The fourth modularserviceability sled 1802D may have an environmental or fluid gasket anda shielding component configured to engage the base assembly 1804.

In at least one example embodiment, the fifth sled 1802E includes abottle tray load cell assembly. The bottle tray load cell assembly maybe similar to or the same as the load cell assembly 1500 of FIGS.15A-15M. The bottle tray load cell assembly may be configured to have anelectrical power connection and a signal connection with the baseassembly 1804. The fifth modular serviceability sled 1802E may have anenvironmental or fluid gasket and a shielding component configured toengage the base assembly 1804.

In at least one example embodiment, the sixth sled 1802F includes a userinterface device or screen. The user interface device may be configuredto have an electrical power connection and a signal connection with thebase assembly 1804. The sixth modular serviceability sled 1802F may havean environmental or fluid gasket and a shielding component configured toengage the base assembly 1804.

In at least one example embodiment, the seventh sled 1802G includes abarcode scanner configured to have an electrical power connection and asignal connection with the base assembly 1804. The seventh modularserviceability sled 1802A may have an environmental or fluid gasket anda shielding component configured to engage the base assembly 1804.

In at least one example embodiment, the eighth sled 1802H includes asoft cassette assembly. The soft cassette assembly may be similar to orthe same as the soft cassette assembly 300 of FIG. 3A. The soft cassetteassembly may be configured to have an electrical power connection, anelectrical communication connection, and a pneumatic connection with thebase assembly 1804. The eighth modular serviceability sled 1802H mayhave an environmental or fluid gasket and a shielding componentconfigured to engage the base assembly 1804.

In at least one example embodiment, the ninth sleds 1802I include hangerassemblies (e.g., for AC and/or saline bags). The hanger assemblies maybe similar to or the same as the soft the first and second hangerassemblies 2200, 2202 of FIG. 21A. One or both of the hanger assemblies(e.g., a hanger assembly for the saline bag) may be configured to haveelectrical power connections with the base assembly 1804. The ninthmodular serviceability sleds 1802I may have environmental or fluidgaskets and shielding components configured to engage the base assembly1804.

In at least one example embodiment, when the modular serviceabilitysleds 1802 are in respective receiving spaces 1806 of the apheresissystem 1800 and coupled to the base assembly 1804, an interior region1808A of the apheresis system 1800 is electrically shielded from anexterior region 1808B of the apheresis system 1800 via at least onemetal component (e.g., base plate, shielding gasket) between theinterior region 1808A and the exterior region 1808, as shown anddescribed below in the discussion accompanying FIG. 18D.

FIG. 18B is a schematic sectional view of a modular serviceability sledof the apheresis system of FIG. 18A in a disengaged state according toat least one example embodiment.

In at least one example embodiment, the sled 1802 (e.g., any of thesleds 1802A, 1802B, 1802C, 1802D, 1802E, 1802F, 1802G, 1802H, 1802I)includes a base plate 1814, an internal support structure 1816, a gasket1818 (e.g., an environmental or fluid gasket), and a shielding component1820. In the example embodiment shown, the gasket 1818 and the shieldingcomponent 1820 are distinct components; however, in other exampleembodiments, a single component may be configured to replace the gasket1818 and shielding component 1820. In at least one example embodiment,the internal support structure 1816 is an internal support panel. One ormore of the base plate 1814, the internal support structure 1816, thegasket 1818, and the shielding component 1820 may cooperate to define amodular frame 1822.

In at least one example embodiment, the modular serviceability sled 1802includes at least one internal system subassembly 1824 attached to themodular frame (e.g., one or more of the base plate 1814 and the internalsupport structure 1816). The internal system subassembly 1824 may beattached to the base plate 1814 and/or the internal support structure1816 via a first bracket 1826 and/or a second bracket 1828. The brackets1826, 1828 may be independently selected from a standoff, a washer,captured nut, a sheet metal adapter, a spacer block, other mechanicalelements, or any combination thereof.

In at least one example embodiment, the internal system subassembly 1824is a discrete station, portion, or assembly of the apheresis system1800. In at least one example embodiment, the apheresis system 1800includes a plurality of internal system subassemblies 1824. Each of theinternal system subassemblies 1824 may be configured to operateindependently of other internal system subassemblies 1824 (e.g., onother sleds 1802).

In at least one example embodiment, each of the sleds 1802 includes amemory storage device (e.g., similar to or the same as memory 1008and/or memory 1108) that forms a part of the internal system subassembly1824 and/or external system subassembly 1830. The memory storage devicemay store, embed, or otherwise include a code that uniquely identifiesthe sled 1802 and distinguishes it from the other sleds 1802. When themodular serviceability sled 1802 is communicatively coupled with theapheresis system 1800 (e.g., via at least one of the interconnections1832) the apheresis system 1800 (e.g., the controller 1004, 1104, etc.)may be configured to read the code of the memory storage device toidentify the sled 1802.

In at least one example embodiment, the internal system subassembly 1824includes one or more sled interconnections 1832 (e.g., two or more,three or more, or four or more). In at least the example embodimentshown, the internal system subassembly 1824 includes a first sledinterconnection 1832A and a second sled interconnection 1832B. Theinterconnections 1832 may be independently selected from a pneumaticconnection, a hydraulic connection, an electrical power connection, anelectrical communications connection (CAN), and a signal connection. Inat least one example embodiment, the first sled interconnection 1832A isa pneumatic connection and a second sled interconnection 1832B is anelectrical connection (e.g., power and/or communications).

In at least one example embodiment, a respective communication path 1834may connect the internal system subassembly 1820 to each of the sledinterconnections 1832. The base plate 1814 may include or define one ormore junctions 1836 through which the communications paths 1834 extend.The junctions 1836 may be independently selected from sealed and/orhermetic pass-throughs, an electrical vias, and/or passages or holes. Inat least the example embodiment shown, the first communication path1834A connects the external system subassembly 1830 to the first sledinterconnection 1832A via a first junction or passage 1836A and thesecond communication path 1834B connects the external system subassembly1830 to the second sled interconnection via a second junction or 1836B.In at least one other example embodiment, more than one communicationpath extends through a common or shared junction in a base plate.

In at least one example embodiment, the sled 1802 further includes thegasket 1818. The gasket 1818 may be on an underside 1842 of the baseplate 1814. The gasket 1818 may be configured to engage the baseassembly 1804, such as the housing 1804A of the base assembly 1804(shown in FIG. 18A) to form a fluid and/or environmental seal betweenthe interior and exterior regions 1808A, 1808B (shown in FIG. 18A) ofthe base assembly 1804. In at least the example embodiment shown, thegasket 1818 is a flat gasket; however, a gasket may have any desiredcross-sectional shape, such as rectangular, square, round, etc., and maybe solid or hollow. In at least one example embodiment, the gasket 1818includes an O-ring, an O-ring chord, a chord seal, a die-cut gasket, afoam gasket, a form-in-place gasket (e.g., a robotically-applied resinthat cures to form a gasket, a foam-in-place gasket) or any combinationthereof.

In at least one example embodiment, the sled 1802 further includes theshielding component 1820. In at least the example embodiment shown, theshielding component 1820 is a conductive gasket (e.g., a hollow chordgasket having metal shavings therein); however, a shielding componentmay have any desired form and include a metal, including gaskets havingother cross-sectional shapes or a metal component (e.g., a metal spring,canted coil spring, metallized fabric, metal contact spring, or anycombination thereof). The shielding component 1820 may be on theunderside 1842 of the base plate 1812 (e.g., in direct contact with theunderside 1842 of the base plate 1814). The shielding component may beconfigured to engage (e.g., directly contact) the base assembly 1804,such as the frame 1804B of the base assembly 1804 (shown in FIG. 18A)when the sled 1802 is attached to the apheresis system 1800. Theshielding component 1820 may be configured to shield electromagneticinterference (EMI) and/or radio frequency interference (RFI). In atleast the example embodiment shown, the shielding component 1820 is ashielding gasket that is concentrically inside of the gasket 1818.

In at least one example embodiment, the sled 1802 defines one or morereceptacles 1846. In at least the example embodiment shown, thereceptacles 1846 are countersunk holes; however, in at least one otherexample embodiment, the receptacles 1846 are through-holes, counterboredholes, countersunk holes, and/or any combination thereof. In at leastone example embodiment, the receptacles 1846 may be sized and/or shapedto receive a respective fastener (see, e.g., fasteners 1852 shown inFIG. 18C) when the sled 1802 is in an engaged state with the baseassembly 1804 (shown in FIG. 18D).

FIG. 18C is a bottom perspective view of the second sled 1802 inaccordance with at least one example embodiment.

In at least one example embodiment, as shown in FIG. 18C, the secondsled 1802B is provided. The second sled 1802 includes a base plate 1814′and an internal support structure 1816′. The sled 1802B further includesan environmental gasket 1818′ a shielding component 1820′. The othersleds 1802A, 1802C, 1802D, 1802E, 1802F, 1802G, 1802H, 1802I may includesimilar features.

FIG. 18D is a schematic sectional view of the modular serviceabilitysled of FIG. 18B in an engaged state according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 18D, the sled 1802may be operatively engaged with a base assembly 1804′. The base assembly1804′ may be a simplified version of the base assembly 1804 of FIG. 18Asuch that a housing and frame of the base assembly 1840′ are shown asintegral. However, the sled 1802 may alternatively be coupled to thebase assembly 1804 of FIG. 18A, which includes the distinct housing1804A and frame 1808B.

In the engaged state, each of the sled interconnections 1832 isoperatively engaged with a respective machine interconnection 1850. Inat least one example embodiment, the sled interconnections 1832 may beindependently selected from a plug and a socket and the machineinterconnections 1850 may be the other of the plug and the socket.Additionally or alternatively, sled interconnections may includepush-to-connect fittings where tubing is directly inserted into afitting and/or barb fittings (e.g., for pneumatics). In at least theexample embodiment shown, the first sled interconnection 1832A isoperatively connected to a first machine interconnection 1850A and thesecond sled interconnection 1832B is operatively connected to a secondmachine interconnection 1850B.

In at least one example embodiment, the sled 1802 is mechanicallycoupled to the base assembly 1804 by one or more fasteners 1852. Each ofthe fasteners 1852 may extend through a respective one of thereceptacles 1846 in the base plate 1814 and engage the base assembly1804 (e.g., the frame 1804B, with the housing 1804A disposedtherebetween). In at least one the example embodiment shown, thefasteners 1852 include flat head cap screw that are threadedly engagedwith threaded holes 1854 defined by the base assembly 1804 (e.g.,press-in inserts in the frame 1804B). In at least one other exampleembodiment, the sled 1802 may be coupled to the base assembly 1804 byother fasteners that do not necessarily use threaded receptacles, suchas quarter turns with custom receptacles.

In at least one example embodiment, the sled 1802 is configured to becompletely removed from the apheresis system 1800 by removing thefasteners 1852. In at least one example embodiment, each of the sleds1802 is configured to be coupled to the base assembly 1804 by a limitedquantity of fasteners 1852 to facilitate quick removal, replacement,and/or attachment. In at least one example embodiment, the quantity offasteners 1852 is less than or equal to 5 (e.g., less than or equal to4, less than or equal to 3, or less than or equal to 2).

In at least one example embodiment, in the engaged state, the gasket1818 engages (e.g., is compressed) between the base plate 1814 and thebase assembly 1804 (e.g., the housing 1804A of the base assembly 1804).Accordingly, the gasket 1818 is configured to reduce or prevent transferof fluid and/or particles between the external and internal regions1808B, 1808A of the base assembly 1804. In at least one exampleembodiment, the gasket 1818 forms a fluid and/or environmental sealbetween the external and internal regions 1808B, 1808A of the baseassembly 1804.

In at least one example embodiment, in the engaged state, the shieldingcomponent 1820 contacts the base plate 1804 and the base assembly 1804(e.g., the frame 1804B of the base assembly 1804). In at least oneexample embodiment, the shielding component 1820 directly contacts thebase plate 1814 and/or the base assembly 1804. In the engaged state, theshielding component 1820 forms an EMI or RFI shield between the externaland internal regions 1808B, 1804A.

FIG. 18E is a flowchart illustrating a method of servicing an apheresissystem according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 18E, the methodgenerally includes detaching a sled from a base assembly of theapheresis system at S1860A; at least partially removing the sled from areceiving space in the housing at S1860B; disconnecting sledinterconnection(s) from machine interconnection(s) at S1860C; servicingthe sled at S1860D; connecting the sled interconnections with themachine interconnections at S1860E; disposing the sled at leastpartially within the receiving space of the housing at S1860F; andattaching the sled to the housing at S1860G. Each of these steps isdescribed in greater detail below. The method is described in thecontext of the apheresis system 1800 of FIGS. 18A-18D; however, itshould be appreciated that the method is also applicable to otherapheresis systems having modular serviceability sleds.

In at least one example embodiment, at S1860A, the method includesdetaching a sled from a base assembly of the apheresis system. In atleast the example embodiment shown, the sled 1802 may be detached fromthe base assembly 1804 by removing the fasteners 1852 from the threadedholes 1854 in the base assembly 1804 (e.g., the frame 1804B) and thereceptacles 1846 in the sled 1802.

In at least one example embodiment, at S1860B, the method includes atleast partially removing the sled from a receiving space in the baseassembly. In at least the example embodiment shown, removing the sled1802 from the receiving space 1806 includes moving the sled 1802 awayfrom the base assembly 1804. When receiving space is in a top of thehousing 1802, the sled 1802 may be lifted from the base assembly 1804.Travel of the sled 1802 away from the base assembly 1804 may be limitedby shortest combined length of a pair of sled and machineinterconnections 1832, 1850.

In at least one example embodiment, at S1860C, the method includesdisconnecting sled interconnection(s) from machine interconnection(s).In at least the example embodiment shown, disconnecting may includeseparating plug and socket pairs of the interconnections 1832, 1850.

In at least one example embodiment, at S1860D, the method includesservicing the sled at S1860D. Servicing the sled may includemaintaining, repairing, or replacing the sled 1802.

In at least one example embodiment, at S1860E, the method includesconnecting the sled interconnections with the machine interconnections.In at least one example embodiment connecting the sled interconnections1832 with the machine interconnections 1850 may include operativelyengaging a plug of one of the connections with a socket of the otherinterconnection. Prior to operatively connecting, the sled 1802 may bemoved toward the base assembly 1804 such that the sled interconnection1832 can reach the respective machine interconnection 1850. This mayinclude disposing the sled 1802 at least partially within the receivingspace 1806.

In at least one example embodiment, at S1860F, the method includesdisposing the sled at least partially within the receiving space of thehousing. In at least one example embodiment, after operativelyconnecting the sled and machine interconnections 1832, 1850, the sled1802 may be fully seated within the receiving space 1806.

In at least one example embodiment, at S1860G, the method includesattaching the sled to the base assembly. In at least the exampleembodiment shown, attaching the sled 1802 to the base assembly 1804 mayinclude replacing the fasteners 1852 through the receptacles 1846 andinto the threaded holes 1854. In at least one example embodiment, as thefasteners 1852 are tightened, the base plate 1814 is clamped against thebase assembly 1804 and the gasket 1818 may compress therebetween. Thisclamping and compression of the gasket 1818 may provide an environmentaland/or fluid seal between exterior and interior regions 1808B, 1808A, atleast around the modular serviceability sled 1802. In at least oneexample embodiment, the shielding component 1820 simultaneously contactsboth the base assembly 1804 and the modular frame 1822 to provide an EMIshield and/or an RFI shield.

In at least one example embodiment, the design of the modularserviceability sled 1802 facilitates a quick exchange of subassemblieswithin the apheresis system 1800, such as for maintenance, replacement,and/or repair of a defective, inoperable, or worn subassemblies, or asubassembly that is due for maintenance. In at least one exampleembodiment, a sled is configured to be serviced in a time period of lessthan about 15 minutes (e.g., less than or equal to about 10 minutes,less than or equal to about 5 minutes, less than or equal to about 4minutes, less than or equal to about 3 minutes, less than or equal toabout 2 minutes, or less than or equal to about 1 minutes).

Exemplary aspects are directed to a modular serviceability sled,comprising: a frame comprising a mount plate having a first surfacefacing an interior side of the frame and having a second surface facingan exterior side of the frame; a subassembly attached to the mount plateat the interior side of the frame; an interconnection operativelyconnected to the subassembly, the interconnection comprising at leastone of a socket and plug that engages with a mating interconnection of amachine; a gasket attached to the mount plate adjacent a periphery ofthe mount plate, wherein the gasket comprises a compliant elasticmaterial; and a shielding gasket attached to the mount plate within aperiphery of the gasket on the interior side of the frame, the shieldinggasket corresponding to at least one of an electromagnetic interference(EMI) shielding gasket, radio frequency interference (RFI) shieldinggasket; wherein the modular serviceability sled, in an engaged state, isdisposed at least partially within a receiving space of the machine andis attached to the machine via a fastener clamping the mount plate andthe machine together, wherein the modular serviceability sled, in adisengaged state, is disposed outside of the receiving space of themachine, and wherein, in the engaged state, the subassembly is shieldedfrom an environment outside of the machine via the mount plate and theshielding gasket.

Any one or more of the above aspects wherein the subassembly comprisesat least one electrical component, pneumatic component, and mechanicalcomponent. Any one or more of the above aspects wherein the electricalcomponent corresponds to a microcontroller, sensor, relay, printedcircuit board, and transformer, wherein the pneumatic componentcorresponds to a fluid reservoir, compressor, solenoid valve, air valve,plenum, and manifold, and wherein the mechanical component correspondsto a linear actuator, load cell, strain gauge, pneumatic cylinder,bladder, balloon, air cylinder, and a motor. Any one or more of theabove aspects further comprising: a second subassembly attached to themount plate at the exterior side of the frame, wherein the secondsubassembly is disposed in the environment outside of the machine, andwherein at least one communication path is disposed between thesubassembly and the subassembly through a portion of the mount plate.Any one or more of the above aspects wherein the shielding gasketcorresponds to a metal spring. Any one or more of the above aspectswherein the gasket corresponds to an O-ring.

Exemplary aspects are directed to an apheresis system, comprising: ahousing having a plurality of sides and a receiving space disposed in atleast one side of the plurality of sides, the receiving space incommunication with an interior space of the apheresis system; a machineinterconnection disposed in the receiving space; a first modularserviceability sled, comprising: a frame comprising a mount plate havinga first surface facing an interior side of the frame and having a secondsurface facing an exterior side of the frame; a subassembly attached tothe mount plate at the interior side of the frame; an interconnectionoperatively connected to the subassembly, the interconnection comprisingat least one of a socket and plug that selectively engages with themachine interconnection; a gasket attached to the mount plate adjacent aperiphery of the mount plate, wherein the gasket comprises a compliantelastic material; and a shielding gasket attached to the mount platewithin a periphery of the gasket on the interior side of the frame, theshielding gasket corresponding to at least one of an electromagneticinterference (EMI) shielding gasket, radio frequency interference (RFI)shielding gasket; wherein the first modular serviceability sled, in anengaged state with the apheresis system, is disposed at least partiallywithin the receiving space and is attached to the housing via a fastenerclamping the mount plate and the housing together, wherein the firstmodular serviceability sled, in a disengaged state, is disposed outsideof the receiving space, and wherein, in the engaged state, thesubassembly is shielded from an environment outside of the apheresissystem via the mount plate and the shielding gasket.

Any one or more of the above aspects wherein, in the engaged state thesubassembly of the first modular serviceability sled is electricallyconnected with the apheresis system via connection of theinterconnection of the first modular serviceability sled with themachine interconnection, and wherein at least one of power andcommunication signals are provided via the connection. Any one or moreof the above aspects wherein the first modular serviceability sledcomprises a memory storage device and a code embedded in the memorystorage device, the code uniquely identifying the first modularserviceability sled from other modular serviceability sleds. Any one ormore of the above aspects wherein upon connecting the first modularserviceability sled with the apheresis system, the apheresis systemreads the code embedded in the memory storage device and identifies thefirst modular serviceability sled. Any one or more of the above aspectswherein the receiving space comprises a plurality of receiving spaces,wherein the first modular serviceability sled is engaged with a firstreceiving space of the plurality of receiving spaces, and wherein theapheresis system further comprises: a second modular serviceability sledengaged with a second receiving space of the plurality of receivingspaces, wherein the second modular serviceability sled comprises: aframe comprising a mount plate having a first surface facing an interiorside of the frame and having a second surface facing an exterior side ofthe frame; a subassembly attached to the mount plate at the interiorside of the frame; an interconnection operatively connected to thesubassembly, the interconnection comprising at least one of a socket andplug that selectively engages with the machine interconnection; a gasketattached to the mount plate adjacent a periphery of the mount plate,wherein the gasket comprises a compliant elastic material; and ashielding gasket attached to the mount plate within a periphery of thegasket on the interior side of the frame, the shielding gasketcorresponding to at least one of an electromagnetic interference (EMI)shielding gasket, radio frequency interference (RFI) shielding gasket;wherein the first modular serviceability sled, in an engaged state withthe apheresis system, is disposed at least partially within thereceiving space and is attached to the housing via a fastener clampingthe mount plate and the housing together, wherein the first modularserviceability sled, in a disengaged state, is disposed outside of thereceiving space, and wherein, in the engaged state, the subassembly isshielded from an environment outside of the apheresis system via themount plate and the shielding gasket.

Example Collection Bottle

FIGS. 19A-19J illustrate a collection bottle 1900 that can be used forvarious operations of the apheresis system 200. For example, thecollection bottle 1900 may aid collection, storage, and transportationof plasma. In at least one example embodiment, the collection bottle1900 may correspond to the plasma collection bottle 122, as describedabove.

The collection bottle 1900 may include a body (also referred to as acanister) 1904 and a cap (also referred to as a lid) 1908. As bestillustrated, for example, in FIG. 19C, the body 1904 may have a firstbody end (also referred to as a top end or open end) 1928 and anopposing second body end (also referred to as a bottom end or closedend) 1930. An elongated portion 1924 may be disposed between the firstbody end 1928 and the second body end 1930 and an interior cavity orspace 1932 may be defined therewithin. In at least one exampleembodiment, the body 1904 may include a sealing edge or surface (alsoreferred to as a ring edge or surface) 1926 formed at the first body end1928. For example, the sealing edge 1926 may be disposed along aperiphery of the body 1924 at the first body end 1928. The sealing edge1926 may include one or more recesses, counterbores, grooves, or anycombination thereof. In at least one example embodiment, as illustrated,the body 1904 may be cylindrical (notwithstanding draft angles, basefeatures, manufacturing tolerances, etc.) centered about a length of alongitudinal axis 1922 extending from the first body end 1928 to thesecond body end 1930. Although the collection bottle 1900 is illustratedas generally cylindrical, it should be appreciated that the collectionbottle 1900 may have a variety of configurations and shapes. In at leastone example embodiment, the body 1904 may be formed using a blow moldingprocess, a thermoforming process, a vacuum forming process, an injectionmolding process, three-dimensional printing, or any combination thereof.In at least one example embodiment, the body 1904 may be transparent ortranslucent.

The lid 1908 may be coupled to the first body end 1928. In at least oneexample embodiment, the lid 1908 may be sealed to the body 1904. Forexample, at least a portion of a perimeter of the lid 1908 may be welded(e.g., laser welded) to a perimeter of first body end 1928. As bestillustrated, for example, in FIG. 19D, the lid 1908 may include a lidbody 1934 defining an outer lid perimeter 1909 and having a first lidside (also referred to as a top lid side or an outer lid side) 1933 andan opposing second lid side (also referred to as a bottom lid side or aninner lid side) 1935. In at least one example embodiment, the lid 1908may include a lid rim 1940 extending from the lid body 1934 towards thesecond side 1935. The lid rim 1940 may be configured to be receivedwithin the interior space 1932. For example, the lid rim 1940 may beconfigured such that an interference fit exists between the lid 1908 andthe sealing edge 1926 of the body 1924. The interference fit may ensureproper contact between the lid 1908 and the body 1904 or sealing orwelding. In at least one example embodiment, the lid rim 1940 mayinclude a chamfered, tapered, or radiused lead-in edge that can help toguide the lid 1908 when aligned with the body 1904 during assemblyand/or manufacturing of the collection bottle 1900. In at least oneexample embodiment, the lid rim 1940 may include an undercut region thatcan serve as a flash trap for melt during welding and/or to eliminatestress concentration at the base of the lid rim 1940.

In at least one example embodiment, as illustrated, for example, in FIG.19F, the lid 1908 may be sealed to the body 1904 along a seal regionthat extends along the periphery of the body 1904 and also the periphery1909 of the lid 1908. For example, preparing the collection bottle 1900may include inserting the lid rim 1940 within the interior space 1932 ofthe body 1904 and moving the lid 1908 in a direction towards the closedbottom end 1930 of the body 1904 until at least a portion of the rim1940 aligns with the sealing edge 1926 of the body 1904. In at least oneexample embodiment, the lid 1908 may be moved in the direction towardthe closed bottom end 1930 until a flange of the lid 1908 contacts theopen edge of the canister 1904. In at least one example embodiment, fullcontact of the rim 1940 and the sealing edge 1926 is not necessary. Forexample, the lid 1908 and the body 1904 may be positioned usingautomation and a gap between the rim 1940 and the sealing edge 1926 maybe acceptable so as to accommodate variations in trimmed surfaces.

Once the lid 1908 is positioned such that the rim 1940 is adjacent ornear the sealing edge 1926, the lid 1908 may be welded to the body 1904and/or the body 1904 to the lid 1908. In at least one exampleembodiment, laser energy may be directed through the sealing edge 1926toward the lid rim 1940. In at least one example embodiment, the body1904 may be rotated about the longitudinal axis 1922 relative to a laseras the laser emits laser light and energy until the laser light weldsthe lid 1908 and the body 1904 together along a seal region. Since thebody 1904 may include a translucent and/or transparent and/ortransmitter material (for example, in at least one example embodiment,the body 1904 may be translucent and/or transparent) and the lid 1908may include an absorber material (for example, in at least one exampleembodiment, the lid 1908 may be opaque), energy from the laser (or otherwelder) may pass through the body 1904 to the rim 1940 inside theinterior space 1932 causing a temperature of the lid rim 1940 toincrease and fuse with the body 1904 along the sealing edge 1926. In atleast one example embodiment, the body 1904 and/or lid 1908 may besterilized prior to and/or after the lid 1908 is attached to the body1904.

In at least one example embodiment, the lid 1908 may include a shieldhandle 1942 coupled to the first lid side 1933. The shield handle 1942may include a disk-shaped portion 1941 and a grip recess 1944 disposedbetween the disk-shaped portion 1941 and the first lid side 1933. In atleast one example embodiment, the shield handle 1942 may extend from acentral point of the first lid side 1933. Although illustrated as adisk, it should be recognized that the disk-shaped portion 1941 may takea variety of configurations. In at least one example embodiment, the lid1908 may be formed using a blow molding process, a thermoformingprocess, a vacuum forming process, an injection molding process,three-dimensional printing, or any combination thereof.

In at least one example embodiment, the collection bottle 1900 includesa fluid port 1936 and a vent port 1938. The fluid port 1936 may beconfigured to receive fluid (e.g., plasma), including fluid enteringand/or drawn back from the collection bottle 1900, while the vent port1938 may be configured to help to control pressure within the collectionbottle 1900, for example, by allowing air to move into and out of thecollection bottle 1900. The fluid port 1936 may be positioned at a firstpoint of the collection bottle 1900, and the vent port 1938 may bepositioned at a second point of the collection bottle 1900 distinct fromthe first point. In at least one example embodiment, the second pointmay be as far as possible away from the first point. For example, theports 1936, 1938 may be diametrically opposed on an outer periphery ofthe collection bottle 1900. In at least one example embodiment, theports 1936, 1938 may be formed in the lid 1908. For example, the fluidport 1936 may be disposed at a first point 1911 of the lid 1908 adjacentto the perimeter 1909 and the vent port 1938 may be disposed at a secondpoint 1913 adjacent to the perimeter 1909 distinct from the first point1911. The first and second points 1911, 1913 may be diametricallyopposed. In one example embodiment, prior to use, for example asillustrated in FIGS. 19A and 19F, a fluid port cap 1912 may be coupledto the fluid port 1936 to help maintain the sterility of the collectionbottle 1900 during transport, shipping, and/or storage (i.e., beforeuse). In at least one example embodiment, as illustrated in FIGS. 19B,19G, and 19H, the tubing 120 of the apheresis system 200 may be coupledto the fluid port 1936. In at least one example embodiment the tubing120 may include one or more connectors 1921. For example, as bestillustrated, for example, in FIG. 19B, the connector 1921 may fit overthe fluid port 1936. In at least one example embodiment, a vent tube1916 may be coupled to the vent port 1938. The vent tube 1916 mayprovide a means to connect a filter (e.g., a microbial filter 1918) tothe vent port 1938 that may be configured to seal the vent path, forexample, when the collection bottle 1900 is filled.

In at least one example embodiment, the lid 1908 may be configured toprotect the collection bottle 1900 during transportation, shipping,and/or handling. For example, the disk-shaped portion 1941 of the shieldhandle 1942 may help to protect the fluid port 1936 and/or the vent port1938 and/or any tubing or the like (e.g., fluid port cap 1912, vent tube1916, cut tubing section 120, etc.) attached thereto, which is oftenbrittle. In at least one example embodiment, the disk-shaped portion1941 of the shielded handle 1942 may define a shield plane 1952 and thefluid port 1936 and/or the outlet port 1938 and/or any tubing or thelike attached thereto may be disposed beneath the shield plane 1952(i.e., between the first lid side 1933 and an exterior-facing surface ofthe disk-shaped portion 1941). The shield plane 1952 may define a firstor guard distance, while the fluid port 1936 and/or the outlet port 1938and/or any tubing or the like attached thereto define a second or tubingdistance that is less than the first distance.

In at least one embodiment, the disk-shaped portion 1941 provides araised support structure that is configured to receive force or weightwithout transferring the force or weight to the fluid port 1936 and/orthe outlet port 1938 and/or any tubing or the like attached thereto. Forexample, the disk-shaped portion 1941 a platform such that othercollection bottles may be stacked (e.g., vertically along thelongitudinal axis, etc.) during shipping and/or storage, for example, asshown in FIG. 19H. Although not illustrated, it should be recognizedthat in at least one example embodiment, a major dimension of thedisk-shaped portion 1941 may be selected such that the disk-shapedportion 1941 extends to cover at least a portion of the fluid port 1936and/or the outlet port 1938 and/or any tubing or the like attachedthereto.

A collection bottle transport package (also referred to as a transportcontainer) 1954 is illustrated in FIG. 19H. The transport container 1954may be configured to carry and/or store one or more rows 1956A, 1956B ofcollection bottles 1900, for example, after collection (i.e., afteruse). For example, as illustrated, the transport container 1954 mayinclude a first row 1956A of collection bottles 1900 and a second row1956B of collection bottles 1900. The collection bottles 1900 in thefirst row 1956A may be arranged side-by-side in one or more columns.Although not illustrated, it should be appreciated that a divider may bedisposed between the one or more columns of the first row 1956A. In atleast one example embodiment, the divider may be a loose divider. In atleast one example embodiment, the divider may include cardboard and/orpaperboard. The collection bottles 1900 in the second row 1956B may alsobe arranged side-by-side in one or more columns. Although notillustrated, it should be appreciated that a divider may be disposedbetween the one or more columns of the second row 1956B. In at least oneexample embodiment, the divider may be a loose divider. In at least oneexample embodiment, the divider may include cardboard and/or paperboard.In at least one example embodiment, dividers separating the one or morecolumns of the first row 1956A may extend to divide the one or morecolumns of the second row 1956B.

The second row 1956B may be stacked on top of the first row of bottles1956A. For example, the closed end 1930 of each collection bottle 1900in the second row 1956B may be in contact with the shield handle 1942 ofa respective collective bottle 1900 in the first row of bottles 1856A.In this stacked configuration, the fluid port 1936 and/or the outletport 1938 and/or any tubing or the like attached thereto of eachcollection bottle 1900 in the first row of bottles 1956A is protectedfrom contact with, and damage from, the second row of bottles 1956B, forexample, via the shield handle 1942. For example, the fluid port 1936and/or the outlet port 1938 and/or any tubing or the like attachedthereto may be physically separated from the adjacent row of bottles,for example, via the shield handle 1942. Although two rows 1956A, 1956Bare illustrated, it should be recognized that the transport container1954 may be configured to include fewer or more rows, including, forexample, five rows of collection bottles 1900.

A width of the transport container 1954 may be a length extending from afirst or left side 1951 to a second or right side 1953. A height of thetransport container 1954 may be a length extending from a third or topside 1955 to a fourth or bottom side 1957. A depth of the transportcontainer 1954 may be defined as the length extending into and/or out ofthe page. Although the transport container 1954 is illustrated asdefining an outer package, it should be recognized that in at least oneexample embodiment, the transport container 1954 may include a firstcontainer that encases the first row 1956A and a second container thatencases the second row 1956B, where the first container and the secondcontainer define the transport container 1954. In at least one exampleembodiment, the transport container 1954, including the first containerand/or the second container, may include a corrugated box. Thecollection bottles 1900 may be easily placed in and/or removed from thetransport container 1954, including the first container and/or thesecond container, by grasping (by a user or robot) the shield handle1942, and more specifically, the grip recess 1944.

In at least one example embodiment, the collection bottle 1900 mayinclude a label 1920. In at least one example embodiment, the label 1920may include a radio frequency identification (RFID) tag, a barcode(e.g., 2D, 3D, etc.), quick response (QR) code, visible code that isprinted to the label, or any combination thereof configured to conveyinformation. The information may include identification information,manufacturing information, and the like. In at least one exampleembodiment, the label 1920 may be read by the scanner 1221 of theapheresis system 200 during setup and/or use of the apheresis system200.

The collection bottle 1900 can be used for various operations of theapheresis system 200. For example, in at least one example embodiment,as illustrated for example in FIGS. 191 and 19J, the collection bottle1900 may be disposed in the plasma collection cradle 232C of theapheresis system 200. In at least one example embodiment, the plasmacollection cradle 232C may be a holder like the holder 1300 illustratedin FIG. 13A. In at least one example embodiment, as best illustratedFIG. 19B, the collection bottle 1900 may be disposed on its side with adownward or declining angle 1902 when positioned in the plasmacollection cradle 232C, such that the fluid port 1936 and/or the tubing120 is at a lowermost position and the vent port 1938 and/or vent tube1916 is at an uppermost position during use. The decline angle 1902 maybe greater than or equal to about one degree to less than or equal toabout thirty degrees, optionally greater than or equal to about twodegrees to less than or equal to about five degrees. As a result of thedeclining angle 1902, as plasma (and/or other fluid) enters thecollection bottle 1900, for example, via the fluid port 1936 and/ortubing 120, gases within the collection bottle 1900 may escape via thevent port 1938 and/or the vent tube 1916. Additionally, oralternatively, as the plasma (and/or other fluid) in the collectionbottle 1900 is moved from the collection bottle 1900 through the tubing120 and into the blood component collection set 500 (e.g., during finalphases of the plasma collection process), air may be drawn into thecollection bottle 1900, for example, via the vent port 1938 and/or venttube 1916. In at least one example embodiment, the exchange of gasesthrough the vent port 1938 and/or vent tube 1916 may be filtered by afilter 1918 (e.g., a microbial filter) disposed in the vent tube 1916.As can be appreciated, this arrangement including the filter 1918 mayhelp to ensure that the pressure in the collection bottle 1900 isbalanced with the environment outside of the collection bottle 1900,such that vacuum or pressure build up in the collection bottle 1900 doesnot affect collection efforts negatively and/or that no additionalequipment is necessary to maintain pressures in the collection bottle1900.

In at least one example embodiment, the collection bottle 1900 mayinclude one or more tapered and/or keyed and/or angled surfacesconfigured to ensure the collection bottle 1900 is properly aligned withthe apheresis system 200 and/or the plasma collection cradle 232C, 1300.For example, a base 1937 may be coupled to the first lid side 1933 andthe shield handle 1942 may be coupled to a side of the base 1937 awayfrom the first lid side 1933. The base 1937 may include, as illustratedin FIG. 19J, one or more angled portions configured to align with acorresponding angled portion of the cradle 1300, such as represented byline 1939. In at least one example embodiment, the sides of the base1937 nearer to the fluid port 1936 may form a general shape (forexample, a v-shape) that can be aligned with a corresponding shape ofthe cradle 1300 (e.g., alignment surface 1589 as discussed in FIGS.15K-15L). For example, the general shape of the base 1937 may have anangle that corresponds with alignment angle 1590 of the cradle 1300. Inat least one example embodiment, as illustrated, and discussed above inthe context of FIGS. 15K-15L, the corresponding shape of the cradle 1300may include a slot 1592 configured to receive the fluid port 1936. Thesefeatures together work to ensure proper alignment of the collectionbottle 1900 within the cradle 1300.

FIG. 19G is an illustration of the collection bottle 1900 aftercollection (i.e., after use). For example, the collection bottle 1900shown in FIG. 19G may include plasma collected by operation of theapheresis system 200. In at least one example embodiment, once thecollection bottle 1900 is filled with plasma (and/or other fluid), thetubing 120 may be sealed adjacent to the fluid port 1936. For example,the tubing 120 may include a sealed end 1950. In at least one exampleembodiment, the sealed end 1950 of the tubing 120 may be sealed using acrimping process, a heat-sealing process, a radio frequency (RF) sealingprocess, or any combination thereof. In at least one example embodiment,once the collection bottle 1900 is filled with plasma (and/or otherfluid), the vent tube 1916 may be sealed adjacent to the vent port 1938(i.e., between the filter 1918 and the vent port 1938). For example, thetubing 1916 may include a sealed end 1949. In at least one exampleembodiment, the sealed end 1949 of the tubing 1916 may be sealed using acrimping process, a heat-sealing process, a radio frequency (RF) sealingprocess, or any combination thereof.

In at least one example embodiment, the present disclosure provides acollection bottle. The collection bottle may include a canister and alid. The canister may include an elongate body having a closed end andan open end disposed opposite to the closed end, where an interior spaceof the canister is defined extending from the open end to a pointadjacent the closed end. The lid may include a body, a shield handle anda rim. The body may define an outer perimeter of the lid. The body mayinclude a first side and a second side disposed opposite the first side.The shield handle may be attached to the first side of the body. Theshield handle may be offset a distance from the body. The rim may bedisposed around the outer perimeter of the lid. The rim may be disposedwithin the open end of the canister, and the lid may be sealed to thecanister along the outer perimeter of the lid. In at least one exampleembodiment, the shield handle may include a disk-shaped portion having ahandle outer perimeter that is disposed within an area of the outerperimeter of the lid. In at least one example embodiment, the shieldhandle may include a recessed area disposed between the disk-shapedportion and the body of the lid. In at least one example embodiment, thelid may further include a fluid port disposed on the first side of thebody at a first point adjacent to the outer perimeter of the lid. Thefluid port may include an inlet lumen that defines a first flow pathextending from an exterior of the collection bottle to the interiorspace of the canister. In at least one example embodiment, the lid mayfurther include a vent port disposed on the first side of the body at asecond point adjacent to the outer perimeter of the lid, where the firstpoint and the second point may be arranged diametrically opposed to oneanother. The vent port may include a vent lumen that defines a secondflow path extending from the interior space of the canister to anexterior of the collection bottle. In at least one example embodiment,the lid may further include a vent tube attached to the vent port. Thevent tube may include a filter disposed in the vent tube. The filter maybe disposed in the second flow path. In at least one example embodiment,the lid may be sealed to the canister along the outer perimeter of thelid via a laser welded seam between the rim and a ring edge of thecanister. In at least one example embodiment, the canister may be atleast one of transparent and translucent and/or the lid may be opaque.In at least one example embodiment, after filling or after use, the lidmay further include a sealed tubing section attached to the fluid port.For example, the shield handle may be arranged having a shield planedisposed a guard distance measured from the outer lid perimeter of thelid, and the sealed tubing section may include a sealed end that isdisposed a tubing distance measured from the body of the lid. The guarddistance may be greater than the tubing distance.

In at least one example embodiment, the present disclosure provides acollection bottle transport package. The collection transport packagemay include a container having a width and a height. The containerincludes an interior and an exterior, where the interior includes a baseextending planarly along the width of the container. A first row ofcollection bottles may be arranged side-by-side in the interior of thecontainer, and a second row of collection bottles may be arrangedside-by-side in the interior of the container, where each collectionbottle of the first row of collection bottles and the second row ofcollection bottles includes a canister and a lid. The canister includesan elongate body having a closed end and an open end disposed oppositethe closed end, where an interior space of the canister is definedextending from the open end to a point adjacent the closed end. The lidincludes a body and a shield handle attached to the body. The body maydefine an outer perimeter of the lid and may include a first side and asecond side disposed opposite the first side. The shield handle may beattached to the first side of the body. The shield handle may be offseta distance from the body. The shield handle may include a disk-shapedportion that includes a handle outer perimeter that is disposed withinan area of the outer perimeter of the lid. The lid may further include arim disposed around the outer perimeter of the lid and a fluid portdisposed on the first side of the body at a first point adjacent to theouter perimeter of the lid. The fluid port may include an inlet lumendefining a first flow path extending from an exterior of the collectionbottle to the interior space of the canister. The lid may also include asealed tubing section that may be attached to the fluid port, where theshield handle is arranged having a shield plane disposed a guarddistance measured from the body of the lid. The sealed tubing sectionmay include a sealed end that is disposed a tubing distance measuredfrom the body of the lid, and the guard distance may be greater than thetubing distance. The lid may further include a vent port that may bedisposed on the first side of the body at a second point adjacent to theouter perimeter of the lid, where the first point and the second pointmay be arranged diametrically opposed to one another. The vent port mayinclude a vent lumen defining a second flow path extending from theinterior space of the canister an exterior of the collection bottle. Thelid may further include a vent tube attached to the vent port, where thevent tube includes a filter disposed in the vent tube, and the filter isdisposed in the second flow path. The rim of the lid may be disposed inthe open end of the canister, and the lid may be sealed to the canisteralong the outer perimeter of the lid. The closed end of each collectionbottle of the first row of collection bottles may be in contact with thebase of the container. The closed end of each collection bottle of thesecond row of collection bottles may be in contact with a respectiveshield handle of each collection bottle of the first row of collectionbottles. The sealed tubing section of each collection bottle of thefirst row of collection bottles may be separate and apart from thesecond row of collection bottles in the container such that the sealedtubing section of each collection bottle of the first row of collectionbottles may be protected by the shield handle of each collection bottleof the first row of collection bottles.

Methods for Providing Automatic Fluid Flow Adjustments

FIG. 20 shows an example embodiment of a method 2000. In at least oneexample embodiment, an apheresis system 200 as described herein may beconfigured to perform a process such as the method 2000 of automaticallyadjusting, in real time, flow rates for time optimization of operationsby the apheresis system 200. These adjustments may be based on pressure,which may result in fewer alarms being activated during the use of theapheresis system 200 as compared to conventional systems. Such aprocess, as described herein, allows the apheresis system 200 to operatefaster and selectively slow down to adjust and to avoid alarms.

At step 2001, the method 2000 may begin with a donor being connected toan apheresis system 200 as described herein.

At step 2003, a pump, such as one or more of the draw pump 208, thereturn pump 212, or the AC pump 216, may be initiated. The initiation ofone or more of the pumps may prompt the beginning of a flow of fluidinto and through the apheresis system 200.

The one or more pumps may be initiated by a microcontroller within theapheresis system 200. In at least one example embodiment, initiating oneor more of the pumps may comprise applying power to the one or morepumps to begin the flow.

At step 2006, one or more sensors (e.g., sensors 284, 312, 316, 804,808, 812, 816, and/or 912-924, etc.) in the apheresis system 200 maydetect and/or monitor the flow of the fluid into and/or through theapheresis system 200. In at least one example embodiment, in additionto, or alternatively, a state of the tubing 358 may be monitored. Forexample, a sensor (e.g., sensors 284, 312, 316, 804, 808, 812, 816,and/or 912-924, etc.) may be used to determine whether the tubing 358 islargely round or whether the tubing 358 is collapsed or at allcompressed.

The state of the tubing may correspond to an empty or a partially filledfluid state. Additionally or alternatively, the state of the tubing maycomprise a type of a fluid (e.g., air, blood, blood components, plasma,red blood cells, platelets, etc.) contained within the tubing and/orother sections of the blood component collection set 500. For example, atube may collapse due to an incorrectly connected tube or due to acollapsed vein in a donor. A collapsed tube may change shape due topressure caused by one or more of the pumps drawing fluid into thetubing. In at least one example embodiment, the sensors (e.g., sensors284, 312, 316, 804, 808, 812, 816, and/or 912-924, etc.) may be employedto determine the type of the fluid contained within a section of thetubing of the blood component collection set 500 based on a measuredpressure, density, compressibility, resistance, and/or combinationsthereof at one or more points along the section of the tubing 358.

At step 2009, the method 2000 may comprise detecting that the flow offluid is below a predetermined threshold. In at least one exampleembodiment, the flow of fluid below a predetermined threshold may bedetected automatically.

Detecting the flow of fluid is below a predetermined threshold maycomprise measuring a rate of flow through the tubing, identifying acolor of fluid within the tubing, determining a shape of the tubing,detecting a temperature of the fluid, or measuring or determininganother factor relating to the tubing and/or the flow of fluid. Thepredetermined threshold may relate to any one or more of the rate offlow of fluid through the tubing, color of fluid in the tubing, shape ofthe tubing, or another factor. In at least one example embodiment, theapheresis system 200 may be configured to detect one or more of a red, ablue, or a green color of fluid within the tubing.

At step 2012, the method 2000 may comprise, in response to detecting theflow of fluid is below the predetermined threshold, adjusting a rate ofone or more other fluids by adjusting a rate of pumping of the one ormore pumps. For example, in response to detecting a flow of fluid isbelow a predetermined threshold rate, a computer system of the apheresissystem 200 may adjust a rate of one or more of the pumps of theapheresis system 200. More specifically, if the detected flow of fluidhas a pressure that is below a predetermined threshold pressure, therate of pumping of the one or more pumps may be slowed down and if theflow of fluid has a pressure that is above a predetermined thresholdpressure, the rate of pumping of the one or more pumps may be sped up.If the flow of fluid recovers such that it is equal to the predeterminedthreshold rate, the apheresis system 200 may adjust the one or morepumps back to their original state. Adjusting the rate of the one ormore of the pumps of the apheresis system 200 may comprise altering anamount of power applied to the one or more pumps. In at least oneexample embodiment, adjusting the rate of the one or more pumps of theapheresis system 200 may include turning off the one or more pumps ofthe apheresis system 200. For example, the one or more pumps may beturned off if the detected flow of fluid is too low. Similarly, the oneor more pumps may be stopped if the apheresis system 200 detects a colorwithin the tubing. If the one or more pumps are turned off, the one ormore pumps may not restart automatically. An operator may be required toacknowledge an alarm condition that caused the one or more pumps to stopand to manually restart the apheresis system 200.

By way of example, a first donor 102 may provide blood having a certainplatelet content that is greater than the platelet content of anotherdonor 102. Continuing this example, at a first-time during processing bythe apheresis system 200, the first donor 102 may provide bloodcomponents that are denser than that of another donor 102 at the sametime during processing. In this instance, the apheresis system 200 maydetermine the density, or packing, of the tubing at the first time andadjust the pump pressure from a first pressure to a higher secondpressure. While the first pressure may be sufficient to pump the bloodcomponents through the blood component collection set 500 for anotherdonor 102 in a given time period, the first pressure may be too low topump the denser blood components of the first donor 102 within the giventime period (e.g., requiring more time for the first donor 102 to beprocessed). At least one advantage of the automatic adjustment,described herein, is that the first donor 102 may be processed moreefficiently and in accordance with the characteristics of the firstdonor 102.

Adjusting a rate of one or more pumps in response to detecting a flowbelow a threshold may enable the apheresis system 200 to efficientlypump denser blood components. Since this adjustment is automatic andbased on a detected and determined state of the tubing, the operationsmay be adjusted in real time and without human input. This real-timeautomatic adjustment produces a fast, efficient, processing of donors102, which can result in a more enjoyable donation experience.

Once the state of the tubing is determined, the apheresis system 200 maydetermine whether to adjust a pump pressure (e.g., increase or decreasefrom a predetermined pressure, etc.), cease an operation of theapheresis system 200, advance to a next step in an operation of theapheresis system 200, send a warning message and/or alarm (e.g., causingthe warning message to be rendered to a display device associated withthe apheresis system 200, etc.). In at least one example embodiment,this adjustment may allow processing of blood components to be optimizedfor any number of different donors 102.

At step 2015, the method 2000 may end when the donation process iscomplete. It should be appreciated that the method 2000 may continuethroughout the entire donation process. Rates of flow may be monitoredcontinuously or at intervals and adjustments may be made continuously orat intervals as needed.

At least one example embodiment may include a method comprising:initiating one or more pumps of an apheresis machine; detecting a flowof fluid through the apheresis machine; detecting the flow of the fluidis below a predetermined threshold; and in response to detecting theflow of the fluid is below the predetermined threshold, adjusting a rateof one or more pumps of the apheresis machine.

In at least one example embodiment, detecting the flow of the fluid isbelow the predetermined threshold comprises detecting a collapsed vein.In at least one example embodiment, detecting the flow of the fluid ifbelow the predetermined threshold comprises using a sensor to detect acolor of the fluid. In at least one example embodiment, the sensordetects one or more of red, blue, or green. In at least one exampleembodiment, detecting the flow of the fluid is below the predeterminedthreshold comprises using a sensor to detect a flow rate of the fluid.In at least one example embodiment, detecting the flow of the fluid isbelow the predetermined threshold comprises using a sensor to detect apressure of the flow of the fluid. In at least one example embodiment,detecting the flow of fluid is below the predetermined thresholdcomprises using a sensor to detect a temperature of the fluid. In atleast one example embodiment, adjusting the rate of the one or morepumps of the apheresis machine comprises sending a control signal to theone or more pumps. In at least one example embodiment, adjusting therate of the one or more pumps of the apheresis machine comprisesaltering a power applied to the one or more pumps. In at least oneexample embodiment, adjusting the rate of the one or more pumps of theapheresis machine comprises turning off the one or more pumps.

Example Apheresis System Safety Features

An apheresis system according to at least one example embodiment mayinclude one or more safety features. Safety features may facilitateproper placement of AC and saline bag hooks, provide override access toan interior of a housing, route air to facilitate cooling, and/or reduceor prevent rotation of an unlocked centrifuge.

FIG. 21A is a partial perspective view of the apheresis system of FIG.18A according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 21A, the apheresissystem 1800 includes a first hanger assembly 2200 and a second hangerassembly 2202. The first hanger assembly 2200 includes a first post 2203and a first hook 2204 on the first post 2203. The second hanger assembly2202 includes a second post 2205 and a second hook 2206 on the secondpost 2205.

The first hanger assembly 2200 is configured to hold a first media bag,such as an AC bag (see, e.g., AC bag 114 of FIG. 1 or AC bag 2712 ofFIG. 26G). The second hanger assembly 2202 is configured to hold asecond media bag, such as a saline bag (see, e.g., saline bag 118 ofFIG. 1 or saline bag 2714 of FIG. 26H). The first hanger assembly 2200may be attached to the base assembly 1804 via a first base 2208. Thesecond hanger assembly 2202 may be attached to the base assembly 1804via a second base 2210. An apheresis system according to at least oneexample embodiment may include more post and hooks, such as to holdadditional media bags.

In at least one example embodiment, as will be discussed in great detailbelow, the first and second bases 2208, 2210 may each be differentlyand/or uniquely keyed for receiving one of the first and second posts2203, 2205, but not the other of the first and second posts 2203, 2205.The keyed bases 2208, 2210 may facilitate proper placement of the posts2203, 2205 in the respective bases 2208, 2210. In at least one exampleembodiment, the first post 2203 cannot be inserted into the second base2210 and the second post 2205 cannot be inserted into the first base2208. Additionally or alternatively, the posts 2203, 2205 andcorresponding bases 2208, 2210 may include colors and/or other indiciato facilitate proper placement in the base assembly 1804.

In at least one example embodiment, the first and second hooks 2204,2206 have different shapes, sizes, and/or colors to facilitate properplacement of media bags. In at least one example embodiment, the firsthook 2204 is configured to receive and/or hang a first media bag, butnot a second media bag and the second hook 2206 is configured to receiveand/or hang the second media bag, but not the first media bag. Such aconfiguration may reduce or prevent inadvertent exposure of a donor toAC.

FIG. 21B is an elevation view of a first hanger assembly of theapheresis system of FIG. 21A according to at least one exampleembodiment. FIG. 21C is an exploded perspective view of the first hangerassembly of FIG. 21B according to at least one example embodiment.

In at least one example embodiment, as shown in FIGS. 21B-21C, the firstpost 2203 extends between a first proximal end 2212A and a first distalend 2214A. The first hook 2204 may be at the first distal end 2214A. Thefirst hook 2204 may define a first transverse dimension or width 2216A.

In at least one example embodiment, a first projection 2218A extendsfrom the first proximal end 2212A of the first post 2203. A flange 2220may be between the first proximal end 2212A and the first projection2218A. The first base 2208 may define a first receptacle 2222A. Thefirst receptacle 2222A may be configured to receive at least a portionof the first projection 2218A to couple the first post 2203 to the firstbase 2208. In at least one example embodiment, the first base 2208 isuniquely and/or specifically keyed to receive the first projection2218A.

FIG. 21D is an elevation view of a second hanger assembly of theapheresis system of FIG. 21A according to at least one exampleembodiment. FIG. 21E is an exploded perspective view of the secondhanger assembly of FIG. 21D according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIGS. 21D-21E, thesecond post 2205 extends between a second proximal end 2212B and asecond distal end 2214B. The second hook 2206 may be at the seconddistal end 2214B. The second hook 2206 may define a second transversedimension or width 2216B. The second transverse dimension 2216B may bedifferent than the first transverse dimension 2216A (shown in FIG. 21C).In at least one example embodiment, the second transverse dimension2216B is greater than the first transverse dimension 2216A.

In at least one example embodiment, a second projection 2218B extendsfrom the second proximal end 2212B of the second post 2205. The secondbase 2210 may define a second receptacle 2222B. The second receptacle2222B may be configured to receive at least a portion of the secondprojection 2218B to couple the second post 2205 to the second base 2210.In at least one example embodiment, the second base 2210 is uniquelyand/or specifically keyed to receive the second projection 2218B.

In at least one example embodiment, the first and second posts 2203,2205 have electrical ground connections. The electrical groundconnections may include a metal canted spring that electrically connectsthe respective post 2203, 2205 to a metal frame of the base assembly1804. The electrical ground connection may reduce or prevent EMI limits,so as to meet IEC 60601-1.

In at least one example embodiment, the first post 2203 and/or thesecond post 2205 may be configured to form a further electricalconnection to the apheresis system 1800 (shown in FIG. 21A) wheninserted into the respective receptacle 2208, 2210. In at least oneexample embodiment, the further electrical connection is formed by amultiple conductor electrical connector (not shown) that is configuredto mate with a connector within the base assembly 1804. In at least oneexample embodiment, when an electrical connection is present, the firstpost 2203 and/or the second post 2205 may include an indicator such as avisual indicator. The indicator may, for example, display various colorswhich may indicate corresponding statuses of the apheresis system 1800.In at least one example embodiment, an indicator may display green whenthe apheresis system 1800 is in use and the indicator may display redwhen the apheresis system 1800 is not in use (e.g., due to an end of anapheresis process, an emergency stop, or otherwise). In at least theexample embodiment shown, the second post 2205 includes a furtherelectrical connector and an indicator lamp 2224.

Returning to FIG. 21A, in at least one example embodiment, the apheresissystem 1800 may include an override 2226. The override 2226 may be acord and/or a button that can be depressed by a finger or push rod, orany other type of override. An access panel or door 2228 of theapheresis system 1800 may be locked in the event of a power loss,thereby blocking access to a centrifuge assembly (see, e.g., centrifugeassembly 400 of FIG. 4A or centrifuge assembly 2200 of FIG. 21G) in thebase assembly 1804. The override 2226 may be engaged (e.g., pressed,pulled, etc.) to override the lock and permit opening of the accesspanel 2228. The override 2226 may be connected to a pneumatic actuatorthat controls the access panel 2228. The override 2226 may be configuredto cause the pneumatic actuator to unlock the access panel 2228, therebyenabling access to the centrifuge assembly. In at least the exampleembodiment shown, the override 2226 is on a side of the base assembly1804. However, an override may be disposed anywhere on the aphesissystem that would be accessible in the event of power loss.

FIG. 21F is a perspective view of an air assembly of the apheresissystem of FIG. 21A according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 21F, the apheresissystem 1800 may include an air assembly 2230. The air assembly 2230 maybe in an internal region of the base assembly 1804 (shown in FIG. 21A).The air assembly 2230 may at least partially define a centrifuge regionor chamber 2232 in which the centrifuge is housed. In at least oneexample embodiment, the air assembly 2230 may be configured to maintaina predetermined (or alternatively, desired) temperature or a temperaturerange in the centrifuge chamber 2232. As the centrifuge assemblyoperates, the temperature in the chamber 2232 may rise above apredetermined threshold. In response, the air assembly 2220 maycirculate air in the chamber 2232, and/or vent air from the chamber 2232to an area outside of the apheresis system 1800.

In at least one example embodiment, the air assembly 2230 includes oneor more blowers or fans 2234 configured to circulate air inside thechamber 2232. The blower or fan 2234 may induce an air path that is aconvoluted air path to reduce or prevent fluid (e.g., blood, etc.) fromreaching the air assembly 2230 and/or leaving the apheresis system 1800in the event of a failure or leak from the centrifuge assembly 2240. Inat least one example embodiment, the blower 2234 is configured to drawair out of the chamber 2232.

FIG. 21G is a partial perspective view of a centrifuge chamber of theapheresis system of FIG. 21A according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 21G, the baseassembly 1804 may at least partially define a centrifuge chamber 2235. Asnorkel cap 2236 may be coupled to a wall 2237 of the centrifuge chamber2235. A snorkel 2238 may fluidly connect the centrifuge chamber 2235 toan exterior of the base assembly 1804.

In at least one example embodiment, an airflow path for air exiting thecentrifuge chamber 2235 may include a first portion 2239A, a secondportion 2239B, and/or a third portion 2239C. The first portion 2239Apasses through the snorkel cap 2236 via one or more apertures 2236A. Airmay travel generally horizontally in the first path 2239A. A shape ofthe snorkel cap 2236 may force air in the second portion 2239B to travelinwardly and/or upward. To exit into the snorkel 2238 in the thirdportion 2239C, the air may make about a 90° turn from the second portion2239B. Accordingly, the airflow path including the first, second, andthird portions 2239A, 2239B, 2239C may define multiple bends or curvesthat facilitate trapping of liquid (e.g., blood) while permittingpassage of air. The airflow path may therefore reduce or prevent thetransfer of liquid into the chamber 2232. A centrifuge assembly 2240 maybe in the centrifuge chamber 2235.

FIG. 21H is a perspective view of a centrifuge assembly in a cover lockstate according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 21H, the centrifugeassembly 2240 includes a cover or bell 2242 and a base 2244. Thecentrifuge assembly 2240 further includes a lock assembly 2246 rotatablycoupled the base 2244. The centrifuge assembly 2240 may further includea latch assembly 2248 pivotally coupled to the base 2242. The centrifugeassembly 2240 may be configured to move between a cover lock state inwhich the cover 2242 is fixed with respect to the base 2244 and a coverunlock state in which the cover 2242 is movable with respect to the base2244. The lock assembly 2246 may be configured to move between a latchstate, as shown, and an unlatch state, as shown in FIG. 21O, below.

The centrifuge assembly 2240 may define a centrifuge axis 2249. In atleast one example embodiment, lock assembly 2246 includes a first orcover engagement plate 2252 and a second or latch engagement plate 2252.The cover engagement plate 2250 may be coupled to the latch engagementplate 2252 and configured to rotate about the centrifuge axis 2249together with the latch engagement plate 2252.

In at least one example embodiment, the latch assembly 2248 includes alever 2248A and an engagement component 2248B. The engagement component2248B includes an engagement portion 2248CB, and a counterweight portion2248D. The latch assembly 2248 may be configured to pivot about a latchaxis 2248E. In at least one example embodiment, in the latch assemblymay be configured to automatically move from the unlatch state to thelatch state during operation of the centrifuge assembly 2240. In atleast the example embodiment shown, the counterweight portion 2248D isconfigured to be acted upon by centrifugal force to move the lockassembly 2246 from the unlatch state to the latch state (i.e., pivot thelever 2248A and the engagement portion 2248B about the latch axis2248E).

FIG. 21I is partial exploded perspective view of a latch engagementplate and a latch assembly according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 21I, the latchengagement plate 2252 includes a first annular body 2256, a handle 2258,and a tab 2260. The handle 2258 may be accessible from an exterior ofthe centrifuge assembly 2240 (shown in FIG. 21H) such that a user mayengage the handle 2258 to rotate the latch engagement plate 2252 aboutthe centrifuge axis 2249. The tab 2260 may cooperate with the firstannular body 2256 to at least partially define a receptacle 2262.

In the latched state, the engagement portion 2248C of the latch assembly2248 is at least partially in the receptacle 2262 to prevent rotation ofthe latch engagement plate 2252 in a first rotational direction 2249Aabout the centrifuge axis 2249. In the latch state, as will be describedin greater detail below, the engagement component 2248B of the latchassembly 2248 is outside of the receptacle 2262 to permit rotation ofthe latch engagement plate 2252 in the first rotational direction 2249A.

In at least one example embodiment, the first annular body 2256 of thelatch engagement plate 2252 includes an interior surface 2256A. Theinterior surface 2256A may define a plurality of cutouts 2256B. Each ofthe cutouts 2256B may include a pair of engagement walls 2256C. As willbe described in greater detail below, the engagement walls 2256C may beconfigured to engage a portion of the cover engagement plate 2250 (shownin FIGS. 21A and 21H) to rotate the cover engagement plate 2250 togetherwith the latch engagement plate 2252.

FIG. 21J is a perspective view of a cover engagement plate 2250 of thecentrifuge assembly of FIG. 21H according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 21J, the coverengagement plate 225 includes a second annular body 2266, a plurality ofarms 2268, and a respective plurality of lock tabs 2270. Each of thearms 2268 may extend axially (i.e., substantially parallel to thecentrifuge axis 2249) from the second annular body 2266. Each of thearms 2268 may include a respective one of the plurality of lock tabs2270. In the example embodiment shown, each of the lock tabs 2270extends radially outwardly from a distal end 2268A of a respective oneof the arms 2268. The lock tabs 2270 are configured to engage the cover2242 (shown in FIG. 21K) to retain the cover 2242 in the cover lockstate, as will be described in greater detail below.

In at least one example embodiment, the cover engagement plate 2250further includes a plurality of protrusions 2272. The protrusions 2272may extend axially from the first annular body 2256. The protrusions2272 may be configured to engage the latch engagement plate 2252 (shownin FIG. 21I) to facilitate rotation of the cover engagement plate 2250together with the latch engagement plate 2252. In at least the exampleembodiment shown, each of the protrusions 2272 is configured to engagethe engagement walls 2256C (shown in FIG. 21I) of the latch engagementplate 2252.

FIG. 21K is a perspective view of a cover of the centrifuge assembly ofFIG. 21H according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 21K, the cover 2242includes a body 2274. The body 2274 may at least partially define aninterior region 2276. In at least the example embodiment shown, the body2274 is dome shaped.

The body 2274 includes an interior surface 2274A. In at least oneexample embodiment, the interior surface 2274A defines a plurality ofslots 2274B and a respective plurality of openings 2274C. Each of theslots 2274B may extend in a circumferential direction (e.g., about thecentrifuge axis 2249). Each of the openings 2274C may extend in an axialdirection (i.e., substantially parallel to the centrifuge axis 2249).Each of the openings 2274C may extend between a respective one of theslots 2274B and an end 2274D of the body 2274. In at least the exampleembodiment shown, the cover 2242 may include three slots 2274B and threeopenings 2274C.

In at least one example embodiment, when the centrifuge 2240 (shown inFIG. 21H) is in a cover lock state, the lock tabs 2270 of the coverengagement plate 2250 (shown in FIG. 21J) may be at least partially inthe slots 2274B, respectively. The lock tabs 2270 may engage slot walls2274E to reduce or prevent motion of the cover 2242 along the centrifugeaxis 2249. In at least one example embodiment, when the centrifuge 2240is in a cover unlock state, the lock tabs 2270 may be aligned with theopenings 2274C so that the cover 2242 can be moved with respect to thebase 2244 (shown in FIGS. 21G and 21J) along the centrifuge axis 2249.The lock tabs 2270 may move through the openings 2274C as the cover 2242is lifted from the base 2244.

FIG. 21L is a perspective view of a base of the centrifuge assembly ofFIG. 21H according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 21L, the base 2244includes a cylindrical body 2278 extending between a first or topsurface 2278A and a second or bottom surface 2278B. The top surface2278A may be configured to engage the end 2274D of the cover 2242. Thecylindrical body 2278 may define a plurality of apertures 2278Cextending between the top and bottom surfaces 2278A. 2278B. Each of thearms of the cover engagement plate (shown in FIG. 21J) may extendthrough a respective one of the apertures 2278C.

In at least one example embodiment, the cylindrical body 2278 of thebase 2244 includes an outer annular surface 2278D. The outer annularsurface 2278D may define a latch region 2278E. The latch assembly 2248(shown in FIG. 21H) may be at least partially in the latch region 2278E.

In at least one example embodiment, the base 2244 defines a handleregion 2278F. The handle 2258 of the latch engagement plate 2252 may beconfigured to move within the handle region 2278F. The handle 2258(shown in FIG. 21I) may be at a first end 2278G of the handle region2278F in the cover lock state and a second end 2278H of the handleregion 2278F in the cover lock state.

FIG. 21M is partial bottom perspective view of the centrifuge assemblyof FIG. 21H in the latched state according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIGS. 21L and 21A, inthe latched state, the engagement component 2248B of the latch assembly2248 is at least partially in the recess of the latch engagement plate2252. The tab 2260 of the latch engagement plate 2252 is configured toengage the engagement component 2248B to reduce or prevent motion of thelatch engagement plate 2252 in the first rotational direction 2249A.Movement of the cover engagement plate 2250, which is coupled to thelatch engagement plate 2252, in the first rotational direction 2249A isalso reduced or prevented. Accordingly, the lock tabs 2270 (shown inFIG. 21J) of the cover engagement plate 2250 may be prevented frommoving within the slots 2274B (shown in FIG. 21K) to axially align withthe openings 2274C (shown in FIG. 21I). Thus, in the latched state, thecover 2242 cannot be removed from the base 2244.

In at least one example embodiment, the latch assembly may be moved fromthe latched state to the unlatched state by pivoting the lever about thelatch axis. The engagement component 2248B may pivot together with thelever 2248A such that it is removed from the receptacle 2262.

FIG. 21N is partial bottom perspective view of the centrifuge assemblyof FIG. 21M in the unlatched state according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 21N, when the latchassembly 2248 is in the unlatch state, the engagement component 2248B isnot in the receptacle 2262 of the latch engagement plate 2252.Accordingly, the latch engagement plate 2252 is free to rotate in thefirst rotational direction 2249A without interference from theengagement component 2248B, as shown. The engagement component 2248B maybe spaced apart from the latch engagement plate 2252 along thecentrifuge axis 2249 to define a clearance gap (not shown). In at leastone example embodiment, the latch engagement plate 2252 may be rotatedin the first rotational direction 2249A (e.g., by operator engagementwith the handle 2258, shown in FIG. 21I) until the lock tabs 2270 (shownin FIG. 21J) of the cover engagement plate 2250 are aligned with theopenings 2272 (shown in FIG. 21K) of the cover 2242 (shown in FIG. 21K).

FIG. 21O is a perspective view of the compressor assembly of FIG. 21H ina cover unlock state according to at least one example embodiment.

In at least one example embodiment, the centrifuge assembly 2240 may bemoved from the cover lock state (shown in FIGS. 21A & 21L) to a coverunlock state, as shown in FIG. 21O. To move the centrifuge assembly 2240from the cover lock state to the cover unlock state, the lock assembly2246 may be moved from the latch state to the unlatched state bypivoting the lever 2248A of the latch assembly 2248 about the latch axis2248E. When the lock assembly 2246 is in the unlatched state, the lockassembly 2246 may be rotated in a first rotational direction 2249A aboutthe centrifuge axis 2249, such as by operator engagement with the handle2258 of the latch engagement plate 2252. The operator may move thehandle 2258 from the first end 2278G of the handle region 2278F to thesecond end 2278H of the handle region 2278F to place the centrifugeassembly 2200 in the cover unlock state. In the cover unlock state, thecover 2242 can be separated from the base 2244, as described above.

In at least one example embodiment, the latch assembly 2248 maycorrespond to an over center latch. The apheresis system 1800 maycontrol an initiation, startup, and/or rotation of the centrifugeassembly 2240 by applying a momentary motor output and monitoring halleffect sensors associated with the centrifuge motor. Detection by thehall effect sensors a change in voltage beyond a predetermined range mayindicate that the motor is mot turning and a jam may be present. Inresponse, the apheresis system 1800 may prevent operation of theapheresis system 1800 and determine that the centrifuge 2240 is notlocked. Further, the latch assembly 2248 (e.g., the lever 2248A) mayabut against a chamber of the apheresis system 1800. An alarm may bepresented to the GUI describing the alarm. This arrangement may reduceor prevent the inclusion of additional sensors to the centrifuge.

Embodiments include a system for separating a component from amulti-component fluid comprising: a housing comprising an access doorand a top cover, the access door providing access to a chamber; acentrifuge housed in the chamber and configured to receive themulti-component fluid, the centrifuge configured to rotate to separatethe component the multi-component fluid; a first fluid bag and a secondfluid bag; and a first hook configured to support the first fluid bagand a second hook configured to support the second fluid bag, whereinthe first hook is shaped to receive the first fluid bag and the secondhook is shaped to receive the second fluid bag.

Aspects of the system further comprise a first post and a second post,the first hook disposed at an end of the first post and the second hookdisposed at an end of the second post. Aspects of the system include thetop cover comprising a first recess configured to receive the first postand a second recess configured to receive the second post. Aspects ofthe system include the first recess being keyed to receive the firstpost and the second recess being keyed to receive the second post.Aspects of the system include at least one of the first post and thesecond post comprising an indicator configured to provide a visualdisplay. Aspects of the system include the visual display comprising oneor more colors. Aspects of the system further comprise an overrideconfigured to unlock the access cover when power is lost to the system.Aspects of the system further comprise an air assembly configured tomaintain a temperature range in the chamber. Aspects of the systeminclude the air assembly comprising a fan configured to provide acirculation to the chamber and a temperature sensor configured to sensea temperature in the chamber. Aspects of the system include thecentrifuge comprising a lock configured to prevent the centrifuge fromrotating when the lock is in an unlocked position, wherein the lockprotrudes from the centrifuge and contacts the chamber, therebypreventing rotation when in the unlocked position.

Example Operational Controls Based on Detected Environmental State

During use of the apheresis system 200, if a vein collapses, or flowotherwise drops below a predetermined threshold, the apheresis system200 may be configured to issue an alarm and/or lower the flow rateautomatically. In at least one example embodiment, the vein isstabilized. In at least one example embodiment, the user may check thata needle is properly inserted into a donor. The apheresis system 200may, in at least one example embodiment, automatically attempt torestart the process and increase the flow rate. In at least one exampleembodiment, the apheresis system 200 may also automatically increase aspeed of the centrifuge. For example, while the centrifuge continues tospin, the speed of the centrifuge may be lowered (e.g., from 5,000 rpmto 1,950 rpm) to maintain blood in the bladder of the apheresis system200 at a controlled, predetermined temperature, while the alarm is beingaddressed. The speed of the centrifuge may be configured to maintain thetemperature of the blood at about 42° Celsius or below to prevent damageto the blood. The alarm may be provided to the GUI of the device and mayinclude instructions on how to address and/or resolve the alarm.

The process of issuing alarms and/or lowering flow rates to stabilizeveins may be performed as part of a method such as illustrated in FIG.22A. At 2300, the method of FIG. 22A may begin at which point a donor,such as the donor 102, may be connected to an apheresis system, such asthe apheresis system 200, which may be performing a donation process.

The apheresis system 200 may determine the state of tubing (e.g., in theblood component collection set 500, etc.) engaged with one or morereceiving features (e.g., recesses, channels, raceways, etc.) of theapheresis system 200. Based on the determined state of the tubing, theapheresis system 200 may automatically adjust one or more settings tooptimize operations of the apheresis system 200.

At 2303, the apheresis system 200 may detect a change in flow of a fluidand/or a change in composition of the fluid in one or more tubesconnected to the apheresis system 200. Detecting a change in flow and/ora change in composition of a fluid may comprise analyzing, such asthrough the use of a sensor, flow rate, flow pressure, temperature,color of fluid, shape of tubing, and/or other factors relating to theflow of fluid throughout the apheresis system 200 and tubes connected tothe apheresis system 200. In at least one example embodiment, a changein composition of the fluid may be detected by a change in pressure inthe one or more tubes connected to the apheresis system 200.

In at least one example embodiment, one or more pressure sensors may beused to detect a pressure of fluid and/or air through one or more tubes.For example, if a vein of a donor collapses, a pressure within a tubemay rise or fall. Upper and lower thresholds may be set to detect suchan occasion. In at least one example embodiment, a pressure increase mayindicate that the centrifuge is full or almost full, and thus flowshould be reversed such that blood is returned to the donor.

In at least one example embodiment, one or more color sensors may beused to identify a color of fluid through one or more tubes. Monitoringof situations, conditions, and/or other factors that may affect the endproduct. Conventional systems only monitor a color gram. Among otherthings, the apheresis system 200 may monitor fluids to ensure salinedoes not enter the plasma collection bottle 122. In at least one exampleembodiment, the apheresis system 200 may utilize one or more of a fluidsensor and a color sensor against red, blue, and/or green reflectionand/or transmission. Once red blood cells are detected, the apheresissystem 200 can cease an operation and proceed to push the red bloodcells back to the donor 102.

In at least one example embodiment, the apheresis system 200 may includeat least one temperature sensor. In at least one example embodiment, atemperature sensor may be used to detect a temperature of fluids withinthe apheresis system 200. For example, the apheresis system 200 may beenabled to detect if a fluid, such as blood, falls above or below aparticular temperature. In at least one example embodiment, atemperature sensor may be used to assess a circuit card component and/ordetect a temperature of ambient air.

At 2306, in response to detecting a change in flow of a fluid, theapheresis system 200 may generate and/or issue one or more alarms. Forexample, if a monitored aspect of a flow falls below or rises above apredetermined threshold, an alarm may be triggered.

A threshold may be, for example, a range of colors detectable by a colorsensor, a range of flow rates detectable by a flow rate sensor, a shapeof tubing detectable by a sensor, a range of pressure detectable by apressure sensor, a range of temperatures detectable by a temperaturesensor, etc.

An alarm may comprise one or more of sounds, lights, and a GUI displayand may be configured to alert a user to an occurrence of an event orcondition, such as a threshold being crossed. A GUI display, such as theGUI 1230 shown in FIG. 12B, may, for example, explain the issue orcondition, provide information regarding the issue or condition, and/orprovide instructions to the user.

Generating an alarm may comprise, for example, generating a GUI to bedisplayed on a display device, determining one or more lights on theapheresis system 200 to illuminate, and/or determining one or more audiofiles or sounds to play through speakers, etc.

Issuing an alarm may comprise displaying a GUI on a display device,illuminating one or more lights on the apheresis system 200, and/orplaying one or more audio files or sounds through speakers, etc. In atleast one example embodiment, the apheresis system 200 may include oneor more lights 2339 positioned at the end of one or more supports 2342,as shown in FIG. 22C. Generating and/or issuing an alarm may includeilluminating one or more of the lights 2339. Each of the lights 2339 mayswitch between a plurality of colors depending on the type of the alarmand/or a severity of the alarm, as discussed above.

At 2309, in response to detecting a change in a flow of a fluid, theapheresis system 200 may lower a flow rate through one or more tubes onthe apheresis system 200 such as by adjusting an amount of power appliedto one or more pumps in the apheresis system 200 and/or by adjusting aspeed of the centrifuge. Lowering a flow rate may enable the apheresissystem 200 to stabilize a vein of a donor. Lowering the speed of thecentrifuge may comprise lowering the speed from, for example, 5,000 rpmto 2,500 rpm. In at least one example embodiment, the speed of thecentrifuge may be lowered to about 1,950 rpm. Lowering the speed of thecentrifuge may enable the apheresis system 200 to keep a temperature ofblood in the centrifuge at a particular level.

At 2312, after detecting the change in the flow of the fluid andlowering the flow rate, the apheresis system 200 may be configured toattempt to restart the donation process back to a standard level, forexample, by increasing the flow rate back to a relatively normal rate.

At 2315, the method may end. It should be appreciated that the methoddescribed in relation to FIG. 22A may be repeated as necessary. Forexample, after restarting the donation process, the apheresis system 200may return to step 2303 and continue monitoring flows to detect anychanges.

In at least one example embodiment, a flexible circuit 2336 may bedisposed inside the centrifuge chamber 2333 of the apheresis system 200,as illustrated in FIG. 22C. The flexible circuit 2336 may extend alongone or more walls inside the centrifuge chamber 2333. In at least oneexample embodiment, the flexible circuit 2336 may include traces exposedon a surface facing an interior of the centrifuge chamber 2333. In theevent of a fluid leak (e.g., a blood leak, etc.) inside the chamber2333, the fluid may contact the exposed traces resulting in anelectrical detection of the fluid. This detection may be a difference inresistance, voltage change, and/or the like. In at least one exampleembodiment, the traces may comprise a separation distance between about0.50 mm and about 0.52 mm. In at least one example embodiment, theseparation distance of the traces may be about 0.51 mm. In response todetecting the leak, the apheresis system 200 may cease operations andstop the centrifuge assembly 400 from spinning. In at least one exampleembodiment, a greater separation distance of the traces requires alarger amount of fluid to detect the leak and a smaller separationdistance of the traces requires a smaller amount of fluid to detect aleak. In at least one example embodiment, the flexible circuit 2336 maycomprise reduced susceptibility to changes in humidity. For example, theflexible circuit 2336 may be more resistant to humidity when the tracesare farther apart. In at least one example embodiment, the flexiblecircuit 2336 may operate at humidity levels up to about 80%. Forexample, as illustrated in FIG. 22B, a method of using a flexiblecircuit, such as the flexible circuit 2336, to detect, and respond to, aleak inside a centrifuge chamber may be executed by an apheresis system.In other example embodiments, the flexible circuit 2336 may be of a typenot susceptible to changes in humidity.

At 2318, the method illustrated by FIG. 22B may begin. At the beginningof the method, a centrifuge chamber 2333 of an apheresis system 200 maycontain a spinning centrifuge which may include a liquid. A flexiblecircuit 2336 may be installed on an interior wall of the centrifugechamber. The flexible circuit 2336 may be electrically connected to oneor more microcontrollers and/or computer systems in communication withor of the apheresis system.

At 2321, a processor of the one or more microcontrollers may detect,based on a signal received from the flexible circuit 2336, a leak in acentrifuge chamber, such as the centrifuge chamber 2333.

Detecting a leak may comprise detecting a change in one or more of aresistance, a voltage, a current, or another electrical aspect of theflexible circuit 2336. For example, the processor may monitor aresistance of the flexible circuit 2336. The processor may be configuredto detect the resistance of the flexible circuit 2336 exceeding an upperthreshold or falling below a lower threshold. In response, the processormay determine a leak has occurred.

Similarly, the processor may monitor a voltage and/or a current of theflexible circuit. The processor may be configured to detect the voltageand/or current of the flexible circuit exceeding an upper threshold orfalling below a lower threshold. In response, the processor maydetermine a leak has occurred.

At 2324, in response to the detection of the leak, the processor maystop the rotation of the centrifuge. Stopping the rotation of thecentrifuge may comprise sending a stop signal to a controller incommunication with a motor controlling the speed of the centrifuge ormay comprise ceasing an application of power to a motor, such as byflipping a switch. In at least one example embodiment, the processor maydetermine that a leak has occurred when the centrifuge is not rotating.For example, a standing leak of fluid in a bottom portion of thecentrifuge chamber 2333. In such embodiments, the method may proceedfrom detecting a leak in the centrifuge chamber at 2321 directly togenerating an alarm at 2327, discussed below.

At 2327, in at least one example embodiment, an alarm may be generated.For example, lights, sounds, and/or a GUI element on a display device ofthe apheresis system 200 may be altered to inform a user of theapheresis system 200 that the leak has occurred. In this way, a user maybe enabled to quickly determine a reason as to why the centrifugestopped. A display device, such as the GUI 1230, may instruct the userwith instructions as to how best to remedy the situation. At 2330, themethod may end.

Example embodiments include a method comprising: detecting a change inflow of a fluid; issuing an alarm; lowering a flow rate; and attemptingto restart process and increase the flow rate.

Aspects of the above embodiment include wherein the change in flow is achange in pressure. Aspects of the above embodiment include wherein thechange in flow is associated with a collapsed vein. Aspects of the aboveembodiment include wherein detecting the change in flow of a fluidcomprises detecting a flow rate falls below a threshold. Aspects of theabove embodiment include wherein the change in flow is associated with acolor. Aspects of the above embodiment include wherein detecting thechange in flow comprises using a color sensor to detect a red, blue,and/or green reflection and/or transmission to detect red blood cells.Aspects of the above embodiment include wherein issuing the alarmcomprises using one or more of sound, lights, and a GUI. Aspects of theabove embodiment include wherein the GUI explains an issue and/orprovides instructions to stabilize the vein. Aspects of the aboveembodiment include lowering the flow rate comprising lowering a speed ofa centrifuge from 5,000 rpm to 2,500 rpm to keep temperature of blood ata particular level.

Example embodiments include a method comprising: detecting, with aflexible circuit, a leak in a centrifuge chamber; and in response to thedetecting of the leak, stopping rotation of a centrifuge.

Aspects of the above embodiment include wherein detecting the leakcomprises detecting liquid contacting exposed traces in the flexiblecircuit. Aspects of the above embodiment include wherein the liquidaffects one or more of a resistance, a voltage, and a current. Aspectsof the above embodiment include wherein the flexible circuit is notsusceptible to changes in humidity.

Flexure-Based Tubing State Sensor

FIGS. 23A-23D show various views of a flexure-based tubing state sensor2400 and a flexure block 2404 in accordance with examples of the presentdisclosure. The apheresis system 200 monitors pressure of fluid cominginto and out of the centrifuge assembly 400. In some examples, thispressure may be monitored directly from the surface of one or moresections of the tubing of the blood component collection set 500. Thepressure sensors (e.g., CPS 808, 816, etc.) may measure the pressureusing a lever arm that is in contact with the tubing of the bloodcomponent collection set 500 inserted into the apheresis system 200. Asthe pressure changes, the lever arm may move transmitting pressure fromthe tubing to a pressure sensor. The present disclosure describes aflexure-based tubing state sensor 2400 that is capable of repeatablyproviding pressure measurements without excessive tolerance stack-upbetween the tubing face and the pressure sensor and utilizing fewercomponents than those associated with other designs. Benefits of theflexure-based tubing state sensor 2400 may include, but are in no waylimited to, reduced tolerance stack-up compared to conventionalarrangements (e.g., walls that touch, or contact, the tubing are in thesame flexure block part, which reduces tolerance stack-up, etc.), thespring force of flexures in the flexure block of the flexure-basedtubing state sensor 2400 can be closely controlled (e.g., the flexurescan be molded or machined with high repeatability between parts, etc.),the flexure block of the flexure-based tubing state sensor 2400 can beremoved from the apheresis system 200 and replaced with a new (e.g.,different) flexure block without the need for re-calibration of thesystem (e.g., there is no variations in friction around a pivot pin,etc., since the flexure pivot is part of the flexure block), etc. Anadditional benefit of the flexure-based tubing state sensor 2400 may beversatility because it may be configured to measure pressure of anysoft-walled tubing filled with any liquid, ga, or vapor such that thepressure of the

Referring to FIG. 23A, an elevation section view of the flexure-basedtubing state sensor 2400 is shown in accordance with examples of thepresent disclosure. The flexure-based tubing state sensor 2400 may bemounted to a mount block 2402 (e.g., a portion of the soft cassetteassembly 300, a portion of at least one of the pumps 208, 212, 216, aportion of the housing 204, and/or some other portion of the apheresissystem 200, etc.). In some examples, the flexure-based tubing statesensor 2400 may be used as the CPS 808, 816 described above. Theflexure-based tubing state sensor 2400 may comprise a flexure block 2404and a pressure sensor 2408 interconnected with a controller (e.g.,controller 1004, 1104, etc.) via the electrical connector 2412. A tubingreceiving space 2406 may be disposed on a first side of the mount block2402 and may extend through a top portion of the mount block 2402. Insome example embodiments, the flexure block 2404 may extend through oneor more openings in the mount block 2402 to form the tubing receivingspace 2406 in the mount block 2402. The tubing receiving space 2406 maybe separated from the pressure sensor 2408 via at least one seal 2410.In some example embodiments, the seal 2410 may provide a fluid seal orfluid barrier between the tubing receiving space 2406 and the pressuresensor 2408. The seal 2410 may correspond to a flexible diaphragm seal,a gasket, an O-ring, and/or some other sealing member.

FIG. 23B shows a perspective view of the flexure block 2404 of theflexure-based tubing state sensor 2400 in accordance with examples ofthe present disclosure. The flexure block 2404 may include a flexureblock body 2416 including a first flexure support arm 2424A extending ina first direction from a first side 2430A of the flexure block body2416. In some examples, the first side 2430A may be a fixed element ofthe flexure-based tubing state sensor 2400 and/or the flexure block2404. The flexure block body 2416 may include a second flexure supportarm 2424B extending in second direction from a second side 2430B of theflexure block body 2416. The second side 2430B may also be a fixedelement of the flexure-based tubing state sensor 2400 and/or the flexureblock 2404.

In some example embodiments, the flexure block 2404 may include a leverarm 2434 disposed between the first side 2430A and the second side 2430Band, more specifically, between the first flexure support arm 2424A andthe second flexure support arm 2424B. The lever arm 2434 may include atubing contact section 2435 and a sensor contact section 2436 with acontact finger 2438 such that the lever arm 2434 extends from the tubingreceiving space 2406 to a sensor aperture 2446 of the flexure block body2416. The tubing receiving space 2406 may be arranged between a tubingcontact area of a fixed wall 2420A and the tubing contact section of amoving wall 2420B. The fixed wall 2420A may have a first seal contact2421A and the lever arm 2434 may have a second seal contact 2421B. Insome example embodiments, the moving wall 2420B may be a portion of thelever arm 2434 disposed above the second seal contact 2421B. In someexample embodiments, the seal 2410 may be disposed proximate to thefirst seal contact 2421A and the second seal contact 2421B. For example,the seal 2410 may be coupled with the first seal contact 2421A and thesecond seal contact 2421B. In some example embodiments, one or more ofthe fixed wall 2420A and the moving wall 2420B may optionally include anotch 2422 that may be configured to receive the seal 2410 to create thefluid seal between the tubing receiving space 2406 and the pressuresensor 2408. In some example embodiments, the first seal contact 2421Aand the second seal contact 2421B may not be included in the flexureblock 2404 if the notch 2422 is included in the fixed wall 2420A and themoveable wall 2420B. In some example embodiments, the seal 2410 mayoptionally include a thin membrane or diaphragm portion surrounding themoving wall 2420B. The thin membrane or diaphragm portion of the seal2410 may allow movement of the lever arm 2434 upon a force being appliedto the lever arm 2434 from a pressure change in a tube within the tubingreceiving space 2406.

The lever arm 2434 may be a moveable element of the flexure-based tubingstate sensor 2400 and/or the flexure block 2404 and may be pivotableabout a pivot axis 2442. Among other things, the lever arm 2434 pivotsaround two flexures, a first flexure 2428A and a second flexure 2428B.The first flexure 2428A and the second flexure 2428B may allow the leverarm 2434 to pivot, while minimizing vertical, lateral, and horizontalmovement of the lever arm 2434. The first flexure 2428A and the secondflexure 2428B may maintain the lever arm 2434 in a desired plane and mayprevent movement of the lever arm 2434 in a perpendicular plane. In someembodiments, the first flexure 2428A and the second flexure 2428B may beabout 13 millimeters (mm) thick. In other embodiments, the first flexure2428A and the second flexure 2428B may be thicker, such as about 25 mmthick, to further prevent movement of the lever arm 2434 in anon-desirable plane. In some embodiments, the first flexure 2428A and/orthe second flexure may be formed from a photochemically etched metal. Insome embodiments, forming the first flexure 2428A and/or the secondflexure 2428B from a photochemically etched metal may produce atight-tolerance flexure and the manufacturing process may be repeatable.

In some example embodiments, the first flexure 2428A may extend from thefirst flexure support arm 2424A and join with the lever arm 2434 on afirst side of the lever arm 2434. The second flexure 2428B extends fromthe second flexure support arm 2424B and joins with the lever arm 2434on a second side of the lever arm 2434. In some examples, the virtualintersection of the first flexure 2428A and the second flexure 2428B maydefine the location of the pivot axis 2442. In some embodiments, thepivot axis 2442 may be adjusted to a different location relative to theflexure block 2404 such that movement of the lever arm 2434 is amplifiedwhich may amplify the measured pressure measurements. In some exampleembodiments, the features that surround the first flexure 2428A and thesecond flexure 2428B may be stiffer than the first flexure 2428A and thesecond flexure 2428B to minimize all movement outside of the firstflexure 2428A and the second flexure 2428B.

When the apheresis system 200 is operational, pressure may change in asection of tubing positioned in the tubing receiving space 2406 betweenthe fixed wall 2420A and the moving wall 2420B, the changes in pressuremay cause the section of tubing to expand or contract. Expansion of thesection of tubing may cause a tubing gap distance between the fixed wall2420A and the moving wall 2420B to expand and pivot the lever arm 2434such that the contact finger 2438 moves closer to the sensor aperture2446 of the flexure block body 2416. The pressure sensor 2408 may bedisposed adjacent to the sensor aperture 2446 such that movement of thecontact finger 2438 may apply a pressure to a pressure detection regionof the pressure sensor 2408. Accordingly, the pressure sensor 2408 maydetermine a pressure inside the tubing based on the translated movementto the pressure sensor 2408 via the pivoting of the lever arm 2434 ofthe flexure block 2404. In some example embodiments, a tip of the finger2438 may be curved or rounded such that force from the finger is appliednormal to a surface of the pressure sensor 2408.

In some examples, the flexure block 2404 may be mounted to the mountblock 2402 via the mount flange 2444. The mount flange 2444 maycorrespond to at least one mount surface and may include holes, slots,recesses, and/or apertures that are configured to receive a fastener(e.g., screw, bolt, pin, etc.) to couple the flexure block 2404 to themount block 2402.

The flexure block 2404 may be integrally formed (e.g., machined, molded,wire electrical discharge machined, extruded, 3D printed, selectivelaser sintered, and/or otherwise formed) from a material. The materialmay include plastic, stainless steel, titanium, aluminum, brass, or maybe a different material or a composite such that the flexure block 2404includes more than one material. For example, the first flexure 2428Aand the second flexure 2428B may be formed from a first material and theremainder of the flexure block 2404 may be formed from a secondmaterial. In some example embodiments, the first material may be moreflexible than the second material to facilitate movement of the firstflexure 2428A and the second flexure 2428B upon a pressure change in atube received by the tubing receiving space 2406 while maintaining theremainder of the flexure block 2404 in a rigid or unmoving position orstate.

FIG. 23C shows a schematic diagram of an exaggerated displacement of thefirst flexure 2428A and the second flexure 2428B of the flexure block2404 when a pressure is applied to a tubing section 2450 disposed in thetubing receiving space 2406 of the flexure-based tubing state sensor2400. For example, when the tubing section 2450 is subjected to apressure of 40 pounds per square inch (psi), the tubing section 2450expands in size and increases the gap distance between the fixed wall2420A and the moving wall 2420B at the tubing receiving space 2406. Thisincrease in gap distance causes the lever arm 2434 to pivot about thepivot axis 2442 and move the contact finger 2438 closer to the firstside 2430A of the flexure block body 2416. The amount of thedisplacement is exaggerated to better show the bending motion of thefirst flexure 2428A and the second flexure 2428B. For instance, as thelever arm 2434 of the flexure block 2404 moves from the unpivoted stateshown in FIGS. 23A and 23B, to the pivoted state shown in FIG. 23C, thefirst flexure 2428A may bend in a direction away from the center of theflexure block 2404 and the second flexure 2428B may bend in a directiontoward the center of the flexure block 2404. In some exampleembodiments, in the pivoted state the first flexure 2428A may be bent orcurved as compared to the unpivoted state and the second flexure may bestretched or curved as compared to the unpivoted state. As the pressuredecreases in the tubing section 2450, the lever arm 2434, the firstflexure 2428A, and the second flexure 2428B may return to the positionshown in FIGS. 23A and 23B.

FIG. 23D shows a perspective view of another example embodiment of theflexure block 2404 of the flexure-based tubing state sensor 2400. Theflexure block 2404 shown in FIG. 23D includes the first flexure 2428Aand the second flexure 2428B that both interconnect with a lever arm2434. The pivot axis 2442 may be disposed between the lever arm 2434 andthe body 2416 such that the first flexure 2428A contacts the lever arm2435 between the tubing contact section 2435 and a position on the leverarm 2435 even with the pivot axis and the second flexure 2428B contactsthe lever arm 2434 between the sensor contact section 2436 and aposition on the lever arm 2434 even with the pivot axis. Additionally,the pivot axis 2442 of the flexure block 2404 of FIG. 23D, however, ispositioned at a point where the first flexure 2428A and the secondflexure 2428B overlap but are not in contact with one another. Inparticular, the first flexure 2428A and the second flexure 2428B shownin FIG. 23D are offset from one another in a depth direction and joinwith the lever arm 2434 at different points along the length of thelever arm 2434. It should be appreciated that the description of thecomponents associated with the flexure block 2404 illustrated in FIGS.23A-23C may apply to the components associated with the flexure block2404 illustrated in FIG. 23D.

Exemplary aspects are directed to a flexure-based tubing state sensor,comprising: a flexure block, including a body having a sensor aperture;a lever arm configured to pivot about a pivot axis, the lever armincluding a tubing contact section and a sensor contact section; a firstflexure extending from the body, the first flexure configured to couplewith the lever arm; a second flexure extending from the body, the secondflexure configured to couple with the lever arm; and a fixed wallsection coupled to the body, the fixed wall section disposed offset atubing gap distance from the tubing contact section; wherein the leverarm is pivotable about the pivot axis between an unpivoted state and apivoted state, wherein the sensor contact section of the lever arm isarranged a first distance from the sensor aperture in the unpivotedstate and a second distance from the sensor aperture in the pivotedstate the first distance being greater than the second distance; and apressure sensor comprising a pressure region disposed adjacent thesensor aperture and in contact with the sensor contact section of thelever arm, wherein the pressure sensor detects pressure at the tubingcontact section via rotation of the lever arm and the sensor contactsection acting on the pressure region.

Any one or more of the above aspects further comprising: a section oftubing disposed in between the fixed wall section of the flexure blockand the tubing contact section of the lever arm, wherein a pressureinside the section of tubing causes the section of tubing to change insize, an increase in size of the section of tubing is measured by thepressure sensor as an increased pressure inside the section of tubingand a decrease in size of the section of tubing is measured by thepressure sensor as a decreased pressure in the section of tubing.

At least one example embodiment is directed to a flexure block,comprising: a body having a sensor; a lever arm configured to pivotabout a pivot axis, the lever arm including a tubing contact section anda sensor contact section; a first flexure extending from the body, thefirst flexure configured to couple with the lever arm; a second flexureextending from the body, the second flexure configured to couple withthe lever arm; and a fixed wall section coupled to the body, the fixedwall section disposed offset a tubing gap distance from the tubingcontact section of the lever arm; wherein the lever arm is pivotableabout the pivot axis between an unpivoted state and a pivoted state,wherein the sensor contact section of the lever arm is arranged a firstdistance from the sensor aperture in the unpivoted state and a seconddistance from the sensor aperture in the pivoted state the firstdistance being greater than the second distance.

In some example embodiments, an increase to the tubing gap distancepivots the lever arm about the pivot axis and proportionally moves thesensor contact section closer to the sensor aperture. In some exampleembodiments, the flexure block further comprises a first flexure supportarm and a second flexure support arm, the first flexure support armconfigured to couple with the body and be positioned on a first side ofthe lever arm, the second flexure support arm configured to couple withthe body and be positioned on a second side of the lever arm. In someexample embodiments, the first flexure is configured to couple betweenthe first flexure support arm and the lever arm and the second flexureis configured to couple between the second flexure support arm and thelever arm. In some example embodiments, the body, the first flexuresupport arm, the second flexure support arm, the lever arm, the firstflexure, the second flexure, and the fixed wall section are integrallyformed from a material. In some example embodiments, the material is atleast one of plastic, aluminum, brass, titanium, or stainless steel. Insome example embodiments, the body, the first flexure support arm, thesecond flexure support arm, the lever arm, and the fixed wall sectionare formed from a first material and the first flexure and the secondflexure are formed from a second material, wherein the first material isdifferent from the second material. In some example embodiments, thefirst material is more rigid than the second material. A In some exampleembodiments, the flexure block further comprises a seal configured toprovide a fluid barrier between the sensor aperture and the tubingcontact section of the lever arm. In some example embodiments, at leastone of the lever arm or the fixed wall section includes a notchconfigured to receive the seal. In some example embodiments, at leastone of the first flexure or the second flexure is etched with ageometric pattern. In some example embodiments, moving the lever armfrom the unpivoted state to the pivoted state causes the first flexureto move away from a center of the flexure block and causes the secondflexure to move toward the center of the flexure block. In some exampleembodiments, the pivot axis is defined by a virtual intersection pointof the first flexure and the second flexure. In some exampleembodiments, the pivot axis is disposed along a length of the lever armbetween the tubing contact section and the sensor contact section. Insome example embodiments, the sensor contact section comprises a fingerprotrusion extending in a direction perpendicular to an axis runningalong a length of the lever arm. In some example embodiments, the firstflexure joins the lever arm at a first point adjacent the pivot axis,wherein the second flexure joins the lever arm at a second pointadjacent the pivot axis, and wherein a distance between the first pointand the second point define a width of the lever arm. In some exampleembodiments, the pivot axis is disposed between the lever arm and thebody. In some example embodiments, the first flexure joins the lever armat a first point between the pivot axis and the tubing contact sectionand the second flexure joins the lever arm at a second point between thepivot axis and the sensor contact section.

Example Blood Component Collection Bladder

FIGS. 24A-24J illustrate a blood component collection in accordance withat least one example embodiment of the present disclosure. In at leastone example embodiment, the bladder 536 may be folded and packaged tocreate creases that aid in retaining the blood component collectionbladder 536 inside the collection insert channel 466 of the filler 460of the centrifuge assembly 400. For instance, the blood componentcollection bladder 536 of the blood component collection set 500 may befolded and fastened (e.g., via tape, wrap, etc.) in a folded stateduring packaging. When in the folded state, each fold of the foldedblood component collection bladder 536 may form a crease in the bloodcomponent collection bladder 536. Each crease may remain in the bloodcomponent collection bladder 536 when unfolded or unfurled. When theblood component collection bladder 536 is unfolded and then insertedinto the filler 460, the creases engage with the insert channel of thefiller 460 retaining the blood component collection bladder 536 inplace. In some examples, the filler 460 may comprise a number of tabsdisposed around the collection insert channel 466. The tabs may aid inretaining the blood component collection bladder 536 inside thecollection insert channel 466 of the filler 460. In at least one exampleembodiment, the locations of the tabs may be selected based on alocation of a crease in the blood component collection bladder 536and/or a location of a curve disposed between creases in the bloodcomponent collection bladder 536.

FIG. 24A shows an elevation view of the blood component collection loopof FIG. 5B in accordance with examples of the present disclosure.

In at least one example embodiment, as shown in FIG. 24A, the bloodcomponent collection loop 520 may correspond to the blood componentcollection loop 520 shown in FIG. 5B. For instance, the blood componentcollection loop 520 may include a flexible loop 524 and a bloodcomponent collection bladder 536. The blood component collection bladder536 may be connected to the flexible loop 524 at a bladder loop end 540Aand extend a length 2506 from the bladder loop end 540A to the bladderfree end 540B. In at least one example embodiment, the blood componentcollection bladder 536 may correspond to a laminate sheet (e.g., amulti-layered sheet, etc.) having an overall height 2502 spanning acrossthe length 2506.

The blood component collection bladder 536 may be folded along thelength 2506 to form a folded bladder 2500A. A portion of the foldedbladder 2500A may be wrapped with tape (e.g., a seal tape wrap 2516,etc.), an elastic band (e.g., a rubber band, a silicone band, etc.),shrink wrap, etc., and/or combinations thereof. In at least one exampleembodiment, the folded bladder 2500A may be packaged and shipped in asealed bag.

As shown in FIG. 24A, the blood component collection bladder 536 may befolded along one or more fold lines 2504A-2504D. Although shown as“mountain” fold lines 2504A-2504D, the fold lines 2504A-2504D maycorrespond to “valley” fold lines. In one example, the fold lines2504A-2504D may comprise a combination of mountain and valley foldlines. The fold lines 2504A-2504D may be arranged at different distancesfrom the bladder loop end 540A and/or the bladder free end 540B. Forinstance, a first fold line 2504A is shown disposed a first distancefrom the bladder loop end 540A, a second fold line 2504B is showndisposed a second distance from the bladder loop end 540A greater thanthe first distance, a third fold line 2504C is shown disposed a thirddistance from the bladder loop end 540A greater than the seconddistance, and a fourth fold line 2504D is shown disposed a fourthdistance from the bladder loop end 540A greater than the third distance.Although shown having four separate fold lines 2504A-2504D, the bloodcomponent collection bladder 536 may be folded along more or fewer thanthe fold lines 2504A-2504D shown in FIG. 24A. FIGS. 24B-24D show abottom plan view of the blood component collection loop 520 as the bloodcomponent collection bladder 536 is folded along the fold lines2504A-2504D.

FIG. 24B shows the blood component collection loop of FIG. 24A in afirst folded state in accordance with at least one example embodiment.

In at least one example embodiment, as shown in FIG. 24B, the bloodcomponent collection bladder 536 is folded about the first fold line2504A forming a first fold 2508A in the blood component collectionbladder 536. The remaining fold lines 2504B-2504D, are indicated by thefold line location centerlines 2512B-2512D running from the bladder loopend 540A to the bladder free end 540B of the blood component collectionbladder 536. The second fold location centerline 2512B corresponds tothe location of the second fold line 2504B, the third fold locationcenterline 2512C corresponds to the location of the third fold line2504C, and the fourth fold location centerline 2512D corresponds to thelocation of the fourth fold line 2504D. As illustrated in FIG. 24B, thefirst fold 2508A is made on a first side of the filler loop connector532.

FIG. 24C shows the blood component collection loop of FIG. 24A in asecond folded state in accordance with at least one example embodiment.

In at least one example embodiment, as shown in FIG. 24C, the fourthfold 2508D is formed adjacent the bladder free end 540B (e.g., at thefourth fold line 2504D), and the third fold 2508C is formed (e.g., atthe third fold line 2504C) such that a portion of the blood componentcollection bladder 536 overlaps with itself and the bladder free end540B is protected, or covered, at least partially by the third fold2508C.

FIG. 24D shows the blood component collection loop of FIG. 24A in athird folded state in accordance with at least one example embodiment.

In at least one example embodiment, as shown in FIG. 24D, the bloodcomponent collection bladder 536 is folded at the second fold line 2504Bforming the second fold 2508B. The second fold 2508B is disposed on asecond side of the filler loop connector 532 and the third fold 2508Cand the fourth fold 2508D are brought to the first side of the fillerloop connector 532. In this folded bladder 2500A arrangement, the firstfold 2508A, the third fold 2508C, and the fourth fold 2508D are disposedon the first side of the filler loop connector 532. Additionally oralternatively, the third fold 2508C is disposed adjacent to the firstfold 2508A, and the fourth fold 2508D is disposed adjacent to the fillerloop connector 532.

FIG. 24E is a bottom plan view of the blood component collection loopwith a folded and packaged bladder in accordance with at least oneexample embodiment of the present disclosure;

In at least one example embodiment, the folded bladder 2500A may be heldtogether with a seal tape wrap 2516. The seal tape wrap 2516 maycorrespond to a cold seal tape and/or the like. The seal tape wrap 2516may be fastened around the folded bladder 2500A such that the foldedsections of the blood component collection bladder 536 are held closeto, or in contact with, one another. In some examples, the seal tapewrap 2516 may be wrapped around the folded bladder 2500A on the firstside of the filler loop connector 532. The seal tape wrap 2516 isremoved from the folded bladder 2500A before the folded bladder 2500Acan be unfolded, or unfurled.

FIG. 24F is a perspective view of the blood component collection set ofFIG. 5A in accordance with at least one example embodiment.

In at least one example embodiment, as shown in FIG. 24F, the bloodcomponent collection set 500 includes the blood component collectionloop 520 and the folded bladder 2500A in a packaging arrangement. Inthis packaging arrangement, the blood component collection set 500 maybe sealed inside a plastic bag for transport and/or storage. As shown,the folded bladder 2500A is wrapped with the seal tape wrap 2516,holding the folded bladder 2500A in a folded state.

FIG. 24G is a perspective view of the blood component collection loop ofFIG. 24F without seal tape wrap in accordance with at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 24G, the bloodcomponent collection loop 520 is shown without the seal tape wrap 2516.For the sake of clarity in disclosure, the blood component collectionloop 520 is shown without the other components of the blood componentcollection set 500. In some examples, the folded bladder 2500A mayremain in the folded state even when the seal tape wrap 2516 has beenremoved. Stated another way, the folds in the folded bladder 2500A mayform creases in the blood component collection bladder 536 that, amongother things, give a set shape to the blood component collection bladder536. These creases may remain set in the blood component collectionbladder 536 even when the folded bladder 2500A is unfolded, or unfurled.

FIG. 24H is a top plan view of the blood component collection loop ofFIG. 24A in accordance with at least one example embodiment.

In at least one example embodiment, as shown in FIG. 24H, the bloodcomponent collection loop 520 as the blood component collection bladder536 of the folded bladder 2500A is unfolded from the folded state (shownin FIG. 24G) to an unfolded state. In the unfolded state, the bloodcomponent collection bladder 536 corresponds to a creased bladder 2500B.For example, the blood component collection bladder 536 includes anumber of creases 2520A-2520D that remain set in the material of theblood component collection bladder 536 along the length 2506. Each ofthe creases 2520A-2520D may be formed at a corresponding location ofeach of the folds 2508A-2508D. Stated another way, the folds 2508A-2508Dof the folded bladder 2500A form the creases 2520A-2520D in the creasedbladder 2500B.

In at least one example embodiment, the creased bladder 2500B includes afirst crease 2520A disposed a first distance from the bladder loop end540A, a second crease 2520B disposed a second distance from the bladderloop end 540A, a third crease 2520C disposed a third distance from thebladder loop end 540A, and a fourth crease 2520D disposed a fourthdistance from the bladder loop end 540A. As the creased bladder 2500B isunfurled the creases 2520A-2520D may cause the laminate sheet of theblood component collection bladder 536 to bend in one or more regions.For instance, a first bend in the blood component collection bladder 536may be disposed between the bladder loop end 540A and the first crease2520A. The first bend is shown bending toward a first side 2530A of theblood component collection bladder 536. In at least the exampleembodiment shown, the first bend may form a concave shape on the secondside 2530B of the blood component collection bladder 536 and a convexshape on the first side 2530A of the blood component collection bladder536. A similar bend may be disposed between the first crease 2520A andthe second crease 2520B. This second bend may form a convex shape on thefirst side 2530A of the blood component collection bladder 536 and aconcave shape on the second side 2530B of the blood component collectionbladder 536. Other similar bends may be disposed between the secondcrease 2520B and the third crease 2520C, the third crease 2520C and thefourth crease 2520D, and the fourth crease 2520D and the bladder freeend 540B of the blood component collection bladder 536. In at least theexample embodiment shown, each of these bends may form a convex shape onthe first side 2530A of the blood component collection bladder 536 and aconcave shape on the second side 2530B of the blood component collectionbladder 536.

FIG. 24I is a perspective view of a filler of the centrifuge assembly ofFIG. 4B in accordance with at least one example embodiment of thepresent disclosure.

In at least one example embodiment, as shown in FIG. 24I, the filler 460of the centrifuge assembly 400 is shown in a loading state. In at leastone example embodiment, the filler 460 may comprise a number ofretaining tabs 2522A-2522E disposed along a length of the spiral shapeof the collection insert channel 466. In particular, the plurality ofretaining tabs 2522A-2522E may be disposed, or arranged, along thespiral path at different locations. Each tab of the plurality ofretaining tabs 2522A-2522E may cover a portion of the collection insertchannel 466. The retaining tabs 2522A-2522E may be arranged to coincidewith the bends and/or creases 2520A-2520D in the creased bladder 2500B.In one example, the first retaining tab 2522A may be positioned alongthe substantially spiral path of the collection insert channel 466 tocoincide with the first bend or the first crease 2520A of the creasedbladder 2500B. The second retaining tab 2522B may be positioned alongthe substantially spiral path of the collection insert channel 466 tocoincide with the second bend or the second crease 2520B of the creasedbladder 2500B. The third retaining tab 2522C may be positioned along thesubstantially spiral path of the collection insert channel 466 tocoincide with the third bend or the third crease 2520C of the creasedbladder 2500B. The fourth retaining tab 2522D may be positioned alongthe substantially spiral path of the collection insert channel 466 tocoincide with the fourth bend or the fourth crease 2520D of the creasedbladder 2500B. The fifth retaining tab 2522E may be positioned along thesubstantially spiral path of the collection insert channel 466 tocoincide with the fifth bend or the fourth crease 2520D of the creasedbladder 2500B.

FIG. 24J is a detailed schematic plan view of a section of a collectioninsert channel of the centrifuge assembly of FIG. 24I in accordance withat least one example embodiment.

In at least one example embodiment, as shown in FIG. 24J, the collectioninsert channel 466 includes a retaining tab 2522 covering a portion ofthe collection insert channel 466. A portion of the creased bladder2500B (shown in dashed lines) is shown being retained in the retainingtab 2522 under the retaining tab 2522. In addition to the frictionalcontact between the creases 2520A-2520D and the walls of the collectioninsert channel 466, the creased bladder 2500B may be retained in thecollection insert channel 466 via a retaining surface of the retainingtab 2522 that blocks a path running from the inside of the collectioninsert channel 466 to an outside of the collection insert channel 466.

Exemplary aspects are directed to a blood component collection bladder,comprising: a laminate sheet extending a length from a first end of thelaminate sheet to a second end of the laminate sheet; and a first folddisposed in the laminate sheet a first distance from the first end ofthe laminate sheet; wherein the first fold forms a first crease in thelaminate sheet extending from a first side of a height of the laminatesheet to a second side of the height of the laminate sheet, and whereinthe first crease remains in the laminate sheet when the laminate sheetis in a folded state and when the laminate sheet is in an unfoldedstate.

Any one or more of the above aspects further comprising: a second folddisposed in the laminate sheet a second distance from the first end ofthe laminate sheet, wherein the second distance is greater than thefirst distance, wherein the second fold forms a second crease in thelaminate sheet extending from the first side of the height of thelaminate sheet to the second side of the height of the laminate sheet,and wherein the second crease remains in the laminate sheet when thelaminate sheet is in the folded state and when the laminate sheet is inthe unfolded state. Any one or more of the above aspects furthercomprising: a third fold disposed in the laminate sheet a third distancefrom the first end of the laminate sheet, wherein the third distance isgreater than the second distance, wherein the third fold forms a thirdcrease in the laminate sheet extending from the first side of the heightof the laminate sheet to the second side of the height of the laminatesheet; and a fourth fold disposed in the laminate sheet a fourthdistance from the first end of the laminate sheet, wherein the fourthdistance is greater than the third distance, wherein the fourth foldforms a fourth crease in the laminate sheet extending from the firstside of the height of the laminate sheet to the second side of theheight of the laminate sheet; wherein the third crease and the fourthcrease remain in the laminate sheet when the laminate sheet is in thefolded state and when the laminate sheet is in the unfolded state. Anyone or more of the above aspects wherein the laminate sheet comprises aconnector disposed at the first end, and wherein the laminate sheet issealed at the second end. Any one or more of the above aspects wherein,in the folded state, the first fold is disposed on a first side of theconnector, the second fold is disposed on a second side of theconnector, the third fold is disposed on the first side of theconnector, and the fourth fold is disposed on the first side of theconnector. Any one or more of the above aspects wherein, in the foldedstate, the first fold is disposed adjacent to the third fold and thefourth fold is disposed adjacent the connector. Any one or more of theabove aspects wherein, in the folded state, the laminate sheet ismaintained in the folded state by a section of material wrapped aroundthe laminate sheet on the first side of the connector. Any one or moreof the above aspects wherein, in the unfolded state, the blood componentcollection bladder, when inserted in a collection insert channel of acentrifuge filler is maintained in the collection insert channel by thefirst crease, the second crease, the third crease, and the fourth creasecontacting a wall of the collection insert channel.

Exemplary aspects are directed to a method of loading a centrifugefiller, comprising: providing a blood component collection bladder,comprising: a laminate sheet extending a length from a first end of thelaminate sheet to a second end of the laminate sheet; and a plurality offolds disposed in the laminate sheet, each fold of the plurality offolds arranged at a respective point along the length of the laminatesheet, wherein the respective point is arranged at a respective distancefrom the first end of the laminate sheet, and wherein the respectivedistance is different for each fold of the plurality of folds; whereinthe plurality of folds form a plurality of creases in the laminatesheet, each crease of the plurality of creases extending from a firstside of a height of the laminate sheet to a second side of the height ofthe laminate sheet at the respective point of each fold of the pluralityof folds, and wherein the plurality of creases remain in the laminatesheet when the laminate sheet is in a folded state and when the laminatesheet is in an unfolded state; inserting the blood component collectionbladder in the unfolded state into a collection insert channel of acentrifuge filler such that each crease of the plurality of creasescontacts at least one wall of the collection insert channel; andinverting the centrifuge filler while the blood component collectionbladder is maintained inside the collection insert channel viafrictional contact between the laminate sheet and the collection insertchannel.

Exemplary aspects are directed to a centrifuge assembly, comprising: acentrifuge housing having an internal cavity, wherein the centrifugehousing rotates about a rotation axis of the centrifuge assembly; and afluid separating body disposed at least partially within the internalcavity of the centrifuge housing and configured to rotate relative tothe centrifuge housing about the rotation axis, wherein the fluidseparating body includes a fluid collection insert channel disposed inthe fluid separating body following a substantially spiral path runningfrom a first point adjacent to the rotation axis spirally outward to asecond point disposed adjacent to a periphery of the fluid separatingbody; wherein the fluid collection insert channel comprises a pluralityof tabs arranged along the substantially spiral path at differentlocations, wherein each tab of the plurality of tabs covers a portion ofthe a fluid collection insert channel, wherein each location of thedifferent locations is associated with a corresponding location of abend or crease formed in a blood component collection bladder, andwherein each tab of the plurality of tabs provides a retaining surfacethat blocks a path from inside the fluid collection insert channel to anoutside of the fluid collection insert channel.

Second Example of Soft Cassettes with Integrated Features

FIG. 25A is a perspective view of a soft cassette according to at leastone example embodiment.

In at least one example embodiment, as shown in FIG. 25A, a softcassette 2600 may include one or more features that are similar to orthe same as those of the soft cassette 314 of FIGS. 3A-3D (e.g., havingthe same or similar portions, chambers, flow paths, and/or valveregions). Moreover, the soft cassette 2600 may be used in a softcassette assembly (see, e.g., soft cassette assembly 300 of FIG. 3A orsoft cassette assembly 2650 of FIGS. 25D-25E).

In at least one example embodiment, the soft cassette 2600 includes abody 2602. The body may be formed from the same materials as describedin the discussion of the soft cassette 314, above. In at least oneexample embodiment, the body 2602 defines a first port aperture 2608A, asecond port aperture 2608B, and a first or direct flow lumen 2610between and fluidly connecting the first and second port apertures2608A, 2608B. In at least the example embodiment shown, the softcassette 2600 further includes a first port 2612A at least partially inthe first port aperture 2608A and a second port 2612B at least partiallyin the second port aperture 2608B. In at least one other exampleembodiment, a soft cassette is free of distinct ports, and tubing of acollection set is directly fluidly connected to port apertures withoutdistinct ports therebetween.

In at least one example embodiment, a flow path associated with thedirect flow lumen 2610 may be referred to herein as a “return path.” Inat least one example embodiment, a first chamber 2614 (referred to inother example embodiments as a “drip chamber”) is disposed along thedirect flow lumen 2610 between the first and second port apertures2608A, 2608B. The first chamber 2614 is fluidly connected to the directflow lumen 2610 such that fluid passing through the direct flow lumen2610 also passes through the first chamber 2614.

In at least one example embodiment, the first chamber 2614 is configuredto trap air and/or filter blood components passing therethrough. Theshape of the first chamber 2614 may facilitate trapping air so that itcannot continue through the direct flow lumen 2610 and be passed to adonor. The first chamber 2614 may include a filter (see, e.g., filter2668) therein, as will be described in greater detail below.

In at least one example embodiment, the soft cassette 2600 includes asecond or bypass flow lumen 2616. A second or pressure sensing chamber2618 may be disposed along the bypass flow lumen 2616. The pressuresensing chamber 2618 is fluidly connected to the bypass flow lumen 2616such that fluid passing through the bypass flow lumen 2616 also passesthrough the pressure sensing chamber 2618.

In at least one example embodiment, a flow path associated with thebypass flow lumen 2616 may be referred to herein as a “draw path.” In atleast one example embodiment, the bypass flow lumen 2616 extends betweena first junction 2620A with the direct flow lumen 2610 and a secondjunction 2620B with the direct flow lumen 2610. The bypass flow lumen2616 may include a first bypass branch 2622A extending between the firstjunction 2620A and the pressure sensing chamber 2618 and a second bypassbranch 2622B extending between the second junction 2620B and thepressure sensing chamber 2618.

In at least one example embodiment, the body 2602 includes a perimeterweld or bond 2623A. The perimeter weld 2623A may extend continuously anduninterrupted around a periphery of the body 2602. In at least oneexample embodiment, the body 2602 includes one or more feature welds orbonds 2623B at least partially surrounding other features, such as thelumens 2610, 2616 and the chambers 2614, 2618.

In at least one example embodiment, the soft cassette 2600 includes aplurality of compliant regions or valve paths 2624A, 2624B, 2624C(collectively referred to herein as the “compliant regions 2624”). Thecompliant regions 2624 may be configured to be engaged by respectivevalves of a soft cassette assembly (see, e.g., valves 320A, 320B, 320Cof FIG. 3A) to selectively control fluid flow at a respective locationin the return path or the draw path. In at least the example embodimentshown, the soft cassette 2600 includes three compliant regions 2624. Afirst compliant region 2624A is between the first junction 2620A and thefirst chamber 2614. A second compliant region 2624B is between thesecond junction 2620B and the first chamber 2614. A third compliantregion 2624C is between the first junction 2620A and the pressuresensing chamber 2618.

As described above, the soft cassette assembly may include one or morevalves for selectively controlling the flow of blood to and/or from thedonor 102 (shown in FIG. 1A). In at least one example embodiment, A softcassette assembly may include valve pads or valve regions 2625 disposedat or adjacent to one more discrete flow path points. The valve pads2625 may be disposed to be adjacent to and/or surround compliant regions2624A, 2624B, 2624C of the soft cassette 2600. In at least one exampleembodiment, the valve pads 2625 may provide pinch valve areas at pointsalong the lumens 2610, 2616 of the soft cassette 2600. Forming the valvepads 2625 requires a carefully defined geometry (e.g., especially incross-section), as will be described in greater detail below in thediscussing accompanying FIGS. 25I-25K. In at least one exampleembodiment, a cross-section of the valve pads 2625 may include asemicircular shape on one side of the soft cassette 2600 and a matingopposing (e.g., mirrored) semicircular shape on the other side of thesoft cassette 2600. When joined, the semicircular shapes form a circularcross-sectional shape.

The soft cassette 2600 may define an orthogonal coordinate systemincluding a first or vertical axis 2626A, a second or horizontal axis2626B, and a third or depth axis 2626C. The body 2602 may define a firstdimension or height 2628A parallel to the vertical axis 2626A. The body2602 may define a second dimension or width 2628B parallel to thehorizontal axis 2626B.

FIG. 25B is a side elevation view of the soft cassette of FIG. 25Aaccording to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 25B, the body 2602extends along or defines a first center plane 2630A. The first centerplane 2630A is defined by the vertical axis 2626A and the horizontalaxis 2626B (shown in FIG. 3A). The body 2602 includes a first side orbody portion 2632A on one side of the first center plane 2630A and asecond side or body portion 2632B on the other side of the first centerplane 2630A. As will be described in greater detail below, the first andsecond body portions 2632A, 2632B cooperate to at least partially definethe first and second port apertures 2608A, 2608B (shown in FIG. 25A),the direct flow lumen 2610, the bypass flow lumen 2616 (shown in FIG.25A), the first chamber 2614, the pressure sensing chamber 2618 (shownin FIG. 25A), and/or the compliant regions 2624 (shown in FIG. 25A).

In at least one example embodiment, the first chamber 2614 is reflectionasymmetric about the first center plane 2630A. In at least one exampleembodiment, the first chamber 2614 may have two degrees of rotationsymmetry about an axis parallel to the horizontal axis 2626B. In atleast the example embodiment shown, the first chamber 2614 may includetwo ramped surfaces 2634 and two curved or convex surfaces 2636.

FIG. 25C is a front elevation view of the soft cassette of FIG. 25Aaccording to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 25C, the softcassette 2600 extends along or defines a second center plane 2630Bdefined by the vertical axis 2626A and the depth axis 2626C (shown inFIG. 25A) and a third center plane 2630C defined by the horizontal axis2626B and the depth axis 2626C. The second center plane 2630B may runthrough a center of the width of the body 2602 from the first cassetteend 2602A to the second cassette end 2606B. The third center plane 2630Cmay run through a center of the height of the body 2602 between thefirst cassette end 2606A and the second cassette end 2606B. In at leastone example embodiment, the soft cassette 2600 is asymmetric about thesecond center plane 2630B and/or the third center plane 2630C.

In at least one example embodiment, the body 2602 is asymmetric aboutthe second center plane 2630B. At least a portion of the first chamber2614 may be on one side of the second center plane 2630B and at least aportion of the pressure sensing chamber 2618 may be on the other side ofthe second center plane 2630B. In at least the example embodiment shown,a horizontal center of the first chamber 2614 is on one side of thesecond center plane 2630B and a horizontal center of the pressuresensing chamber 2618 is on the other side of the second center plane2630B. In the example embodiment shown, the entire pressure sensingchamber 2618 is on the other side of the second center plane 2630B. Thefirst chamber 2614 may be reflection asymmetry about the second centerplane 2630B. Respective horizontal centers of the first chamber 2614 andthe pressure sensing chamber 2618 may be offset from one another alongthe horizontal axis 2626B.

In at least one example embodiment, the body 2602 is asymmetric aboutthe third center plane 2630C. At least a portion of the first chamber2614 may be on one side of the third center plane 2630C and at least aportion of the pressure sensing chamber 2618 may be on the other side ofthe third center plane 2630C. In at least the example embodiment shown,the first chamber 2614 is vertically centered on the third center plane2630C and a vertical center of the pressure sensing chamber 2618 is onone side of the third center plane 2630C. In the example embodimentshown, the entire pressure sensing chamber 2618 is on one side of thethird center plane 2630C. The first chamber 2614 may be reflectionasymmetric about the third center plane 2630C. Respective verticalcenters of the first chamber 2614 and the pressure sensing chamber 2618may be offset from one another along the vertical axis 2626A.

The asymmetry may, in at least one example embodiment, facilitate properpositioning and/or orientation of the soft cassette 2600 in a softcassette assembly (see, e.g., the soft cassette assembly 300 of FIG. 3Aor the soft cassette assembly 2650 of FIGS. 25D-25E). Accordingly, theasymmetric arrangement may reduce or prevent inadvertent improperloading of the soft cassette 2600 in the soft cassette assembly, therebyincreasing safety of use and east of operation of a blood componentcollection set (see, e.g., blood component collection set 500) includingthe soft cassette 2600. In at least one example embodiment, a base plateand a cassette access door of the soft cassette assembly may definereceiving spaces that mate with the protruding portions of the softcassette 2600. Because features of the soft cassette 2600 areasymmetrically arranged, the soft cassette 2600 can only be loaded inthe soft cassette assembly 300 in one position and orientation

FIG. 25D is a schematic sectional view of a soft cassette assembly ofthe soft cassette of FIG. 25A according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIG. 25D, the pressuresensing chamber 2618 is unobstructed. In at least one exampleembodiment, a first component or first pressure sensor disk 2642A isdisposed on a first side of the pressure sensing chamber 2618 and asecond component or second pressure sensor disk 2642B is disposed on asecond side of the pressure sensing chamber 2618. In at least oneexample embodiment, the pressure sensor disks 2642A, 2642B may be orinclude circular disks made from a material that is capable of engagingand/or interacting with a magnet, such as a ferromagnetic metal. Theferromagnetic metal may include iron, steel, or other material that iscapable of being attracted by a magnet. The pressure sensor disks 2642A,2642B may consist essentially of the ferromagnetic metal and/or have acoating including the ferromagnetic metal. In at least one other exampleembodiment, the pressure sensor disks 2642A, 2642B may include magnets,such as rare earth magnets, permanent magnets, and/or the like.

In at least one example embodiment, the soft cassette 2600 includes afirst disk cover 2644A and a second disk cover 2644B. The first andsecond disk covers 2644A, 2644B may be substantially circular and have adiameter that is larger than that of the respective pressure sensor disk2642A, 2642B. The first and second disk covers 2644A, 2644B may includethe same material as the body 2602 or a different material than the body2602 (e.g., vinyl, plastic, etc.). The first disk cover 2644A maycooperate with the body 2602 to at least partially define a first pocket2646A. The first pressure sensor disk 2642A may be in the first pocket2646A. The second disk cover 2644B may cooperate with the body 2602 toat least partially define a second pocket 2646B. The second pressuresensor disk 2644B may be in the second pocket 2646B. In at least oneexample embodiment, the first and second pockets 2646A, 2646B are fullyenclosed.

In at least one example embodiment, the soft cassette 2600 may furtherinclude one or more cover welds 2648. Each of the cover welds 2648 mayseal or trap one of the pressure sensor disks 2642A, 2642B in arespective one of the pockets 2646A, 2646B. The welds 2648 may extendaround respective peripheries of the respective disk covers 2644A,2644B.

In at least one example embodiment, a soft cassette assembly 2650 mayinclude a first magnet 2652A and a second magnet 2652B. The secondmagnet 2652B may be operatively connected to a pressure sensor 2654 ofan apheresis system (e.g., the apheresis system 200 of FIG. 1A). In atleast one example embodiment, the pressure sensor 2654 is the same as orsimilar to the pressure sensors 808, 806 of FIG. 8 . The second magnet2652B may be disposed in a portion of a base plate of the soft cassetteassembly 2650 and arranged to magnetically couple to the second pressuresensor disk 2642B of the soft cassette 2600 when the soft cassette 2600is engaged with the soft cassette assembly 2650. In at least one exampleembodiment, such as when the second pressure sensor disk 2642B is amagnet, the soft cassette assembly may alternatively include aferromagnetic metal component (e.g., a distinct component and/or anintegral portion of the assembly).

In at least one example embodiment, a cassette access door 2656 of thesoft cassette assembly 2650 may include the first magnet 2652A embeddedin and/or attached to a portion (e.g., body, etc.) of the cassetteaccess door 2656. When the cassette access door 2656 of the softcassette assembly 2650 is closed (e.g., as shown in FIG. 3A), the firstmagnet 2652A of the cassette access door 2656 may magnetically couple tothe first pressure sensor disk 2642A of the soft cassette 2600. In atleast one example embodiment, this dual magnetic coupling (e.g., betweenthe first magnet 2652A of the pressure sensor 2654 and the opposingsecond magnet 2652B of the cassette access door 2656 may hold the firstpressure sensor disk 2642A and the second pressure sensor disk 2642Bapart at the pressure sensing chamber 2618.

FIG. 25E is a perspective view of the soft cassette assembly of FIG. 25Din an open state in accordance with at least one example embodiment.

In at least one example embodiment, as shown in FIG. 25E, the softcassette assembly 2650 may be similar to the soft cassette assembly 300of FIG. 3A. The soft cassette assembly 2650 may include a base plate302′ and the door 2656. The base plate 302′ and/or the door 2656 maydefine one or more receiving features 312′. The receiving features 312′may be depressions that are sized and shaped to receive at least aportion of the soft cassette 2600 (shown in FIG. 25A), such as thechambers 2614, 2618 and ports 2612A, 2612B (shown in FIG. 25A). The softcassette assembly 2650 may further include fluid control valves 320′.The first magnet 2652A (shown in FIG. 25D) may be in the door 2656 andthe second magnet 2652B and the pressure sensor 2654 may be in the baseplate 302′

FIG. 25F is a partial sectional view of the soft cassette of FIG. 25A ina first pressure state according to at least one example embodiment.FIG. 25G is a partial sectional view of the soft cassette of FIG. 25A ina second pressure state according to at least one example embodiment.

In at least one example embodiment, as the pressure changes inside thepressure sensing chamber 2618 of the soft cassette 2600 (e.g., duringdraw cycles, separation operations, fluid movement through the fluidpressure chamber 2624, etc.), a distance between the first pressuresensor disk 2642A and the second pressure sensor disk 2642B may change.In at least the example embodiment shown in FIG. 25F, a first pressureinside the fluid pressure sensing chamber 2618 may cause the secondpressure sensor disk 2642B to move relative to the first pressure sensordisk 2642A. This movement and associated pressure may be detected as afirst pressure and corresponding internal pressure of the pressuresensing chamber 2618 by the pressure sensor 2654. The first pressure maycorrespond to a first dimension 2660A between the pressure sensor disks2642A, 2642B.

With reference to FIG. 25G, a second pressure greater than the firstpressure inside the pressure sensing chamber 2618 may cause the secondpressure sensor disk 2642B to move relative to the first pressure sensordisk 2642A at an increased movement and/or associated pressure. Thisincreased movement and/or associated pressure may be detected as asecond pressure and a corresponding second internal pressure of thepressure sensing chamber 2618 by the pressure sensor 2654. The secondpressure may correspond to a second dimension 2660B between the pressuresensor disks 2642A, 2642B. The second dimension 2660B may be larger thanthe first dimension 2660A. Based on the pressures detected by thepressure sensor 2654, a controller 2662 (shown in FIG. 25D) (e.g.,controller 1004, 1104, etc.) may control operations of the apheresissystem as described herein.

FIG. 25H is an exploded view of the soft cassette of FIG. 25A accordingto at least one example embodiment. FIG. 25I is another exploded view ofthe soft cassette of FIG. 25A according to at least one exampleembodiment.

In at least one example embodiment, as shown in FIGS. 25H-25I, the body2602 of the soft cassette 2600 includes the first body portion 2632A andthe second body portion 2632B. The soft cassette 2600 may furtherinclude the ports 2612A, 2612B, first and second tubes 2666A, 2666B, afilter 2668, first and second pressure sensor disks 2642A, 2642B, andfirst and second disk covers 2644A, 2644B.

The ports 2612A, 2612B may be each be at least partially between thefirst and second body portions 2632A, 2632B. In at least one exampleembodiments, the ports 2612A, 2612B have different colors and/orgeometries. In at least the example embodiment shown, the second port2612B includes a radially-extending flange 2669 that is not present onthe second port 2612B. The flange (and/or different colors) mayfacilitate proper positioning and/or orientation of the soft cassette2600 in a soft cassette assembly (e.g., the soft cassette assembly 300of FIG. 3A).

The first pressure sensor disk 2642A may be between the first bodyportion 2632A and the first disk cover 2644A. The second pressure sensordisk 2642B may be between the second body portion 2632B and the seconddisk cover 2644B.

In at least one example embodiment, the tubes 2666A, 2666B may be withinthe direct flow lumen 2610 (shown in FIG. 25A) on opposing sides of thefirst chamber 2614 and adjacent to inlet and outlets to the firstchamber 2614. The tubes 2666A, 2666B may be retained between the firstand second cassette body portions 2632A, 2632B. The first tube 2666A maybe between the first junction 2620A and the first chamber 2614. Thesecond tube 2666B may be between the second junction 2620B and the firstchamber 2614. In at least one example embodiment, the tubes 2666A, 2666Bmay reduce or prevent collapsing of the direct flow lumen 2610 to permitfluid within the direct flow lumen 2610 to freely enter and exit thefirst chamber 2614.

In at least one example embodiment, the filter 2668 is within the firstchamber 2614. The filter 2668 is retained between the first and secondcassette body portions 2632A, 2632B. The filter 2668 may be arrangedsuch that all fluid passing through the first chamber 2614 passesthrough the filter 2668. In at least one example embodiment, the filter2668 is configured to reduce or prevent unwanted components in the fluid(e.g., blood) from being exchanged between the donor 102 (shown in FIG.1A) and the apheresis system 200 (shown in FIG. 1A). The filter 2668 maybe or include a screen material (e.g., a 200 micron filter, etc.) thatis between the first and second cassette body portions 2632A, 2632B. Thescreen material may be disposed in a flow path between the cassetteinlet tubing 108A (shown in FIG. 1A) and the loop inlet tubing 108B ofthe extracorporeal tubing circuit. The filter 2668 may separate an innerchamber volume of the first chamber 2614 into a first side associatedwith the cassette inlet tubing 108A and a second side associated withthe loop inlet tubing 108B. Accordingly, blood components flowingthrough the cassette inlet tubing 108A (e.g., in the direction of thedrip chamber 2416) may enter the inner chamber volume on the first sideof the filter 2668 and pass through the filter 2668 to the second sideand into the loop inlet tubing 108B.

FIG. 25J is a flowchart depicting a method of manufacturing a softcassette according to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 25J, a method ofmanufacturing a soft cassette is provided. The method generally includesforming soft cassette body portions at S2670A; coupling one or moredistinct components to one or both body portions at S2670B; disposingone or more distinct components (e.g., a filter, a pump) between thesoft cassette body portions at S2670C; creating lumens, chambers, and/orvalve paths in the soft cassette body portions at S2670D; and formingthe soft cassette by sealing a perimeter of the soft cassette bodyportions at 2670E. The method will be described in the context of thesoft cassette 2600 of FIGS. 25A-25H; however, it should be appreciatedthat the same or a similar method may be used to form other softcassettes (e.g., the soft cassette 314 of FIGS. 3A-3D). Each of thesesteps is described in greater detail below.

At 2670A, the method includes forming first and second body portions2632A, 2632B. In at least one example embodiment, the first and secondbody portions 2632A, 2632B are formed concurrently, such as from asingle sheet of material or multiple sheets of material. After forming,the single sheet of material may be subdivided to separate the first andsecond body portions 2632A, 2632B. Alternatively, the first and secondbody portions 2632A, 2632B may remain part of the single sheet, whichmay be folded onto itself prior to performing subsequent method steps.

In at least one example embodiment, forming the first and second bodyportions 2632A, 2632B includes radio frequency (“RF”) forming. Thematerial sheet(s) may be placed between a pair of dies and subjected toheat and/or pressure to achieve desired shapes and thicknesses in thefirst and second body portions 2632A, 2632B. In at least one exampleembodiment, each of the first and second body portions 2632A, 2632Bincludes a half or portion of the respective features to be formed, suchas the lumens 2610, 2616, chambers 2614, 2618, and compliant regions2624A, 2624B, 2624C. In at least one example embodiment, S2670A includesforming the valve pads 2625. The valve pads 2625 may be formedconcurrently with the lumens 2610, 2616 and the chambers 2614, 2618.

FIG. 25K is a partial sectional view of the soft cassette of FIG. 25Ashowing a valve region. FIG. 25L is a detailed sectional view of thevalve region of FIG. 25K according to at least one example embodiment.

In at least one example embodiment, as shown in FIGS. 25K-25L, the body2602 defines a thickness parallel to the depth axis 2626C. Each of thevalve pads 2625 may define a first thickness 2676A. Other body regions2678, such as those adjacent to the valve pads 2625, may define a secondthickness 2676B. The first thickness 2676A may be less than the secondthickness 2676B. The forming at S2670A may, in some example embodiments,include forming the first and second body portions 2632A, 2632B suchthat the valve pads 2625 have a desired thickness (i.e., half of thefirst thickness 2676A).

Forming the valve pads 2625 to have the desired thickness may beperformed concurrently with the formation of other features in the firstand second body portions 2632A, 2632B, such as the halves of the lumens2610, 2616 and chambers 2614, 2618 (shown in FIG. 25A). In at least oneexample embodiment, the dies are sized and shaped to achieve the desiredthickness. The reduced thickness at the valve pads 2625 facilitates areduction or prevention of material entering a flow region 2680 duringsubsequent forming steps (e.g., 52676D).

Returning to FIG. 25J, at 52676B, in at least one example embodiment,the method may include coupling one or more first distinct components toone or both of the first and second body portions 2632A, 2632B. Thefirst distinct components may include the pressure sensor disks 2642A,2642B. The coupling may include disposing the first pressure sensor disk2642A between the first body portion 2632A and the first disk cover2644A. The coupling may further include disposing the second pressuresensor disk 2642B between the second body portion 2632B and the seconddisk cover 2644B. The coupling may further include bonding the first andsecond body portions 2632A, 2632B to respective first and second diskcovers 2644A, 2644B to trap the respective pressure sensor disks 2642A,2642B therebetween, such as by forming the cover welds 2648.

With continued reference to FIG. 25J, at S2676C, in at least one exampleembodiment, the method includes disposing one or more second distinctcomponents at least partially between the first and second body portions2632A, 2632B. The second distinct component may include the ports 2612A,2612B, the tubes 2666A, 2666B, the filter 2668, and/or any other desiredcomponent (e.g., those described in the discussion accompanying FIG.25M, below).

In at least one other example embodiment, additionally or alternativelyto disposing the ports 2612A, 2612B at least partially between the firstand second body portions 2632A, 2632B, the method may include disposingthe cassette inlet tubing 108A and the loop inlet tubing 108B (shown inFIG. 5A) at least partially between the first and second body portions2632A, 2632B. The cassette inlet tubing 108A may be disposed on thefirst side of the filter 2668 and the loop inlet tubing 108B may bearranged on the second side of the filter 2668.

In at least one example embodiment, the method may include temporarilydisposing a third distinct component between the first and second bodyportions 2632A, 2632B. In at least one example embodiment, the methodincludes disposing one or more mandrels between the first and secondbody portions 2632A, 2632B. The mandrels may be positioned within theflow regions 2680 (shown, for example, in FIG. 25L). The mandrels may besized and shaped to achieve a desired size and shape of the flow regions2680. In at least one example embodiment, the mandrels are a cylindricalmandrels having a diameter corresponding to a desired diameter of theflow region 2680. The mandrels may be formed from a material that willmaintain its integrity during subsequent forming manufacturing steps. Inat least one example embodiment, the mandrels are formed from brass,copper, or any other suitable material.

In at least one example embodiment, at S2670D, the method includescreating the lumens 2610, 2616, the chambers 2614, 2618, and the valvepaths 2624. The method may include aligning the first and second bodyportions 2632A, 2632B such that a first portion/half of each featureopposes a second portion/half of each feature. After aligning, themethod may include bonding or otherwise attaching the first and secondbody portions 2632A, 2632B. In at least one example embodiment, thebonding includes RF welding a periphery of each feature, such as byforming the feature welds 2623B. Accordingly, distinct components thatwere placed in S2670B may be retained or trapped between the first andsecond body portions 2632A, 2632B.

Forming the valve paths 2624 may include applying energy (e.g., RFenergy) at the valve pads 2625 while the mandrel is between the firstand second body portions 2632A, 2632B. The presence of the mandrelfacilitates formation of a flow region 2680 having a desired size andshape, such as cylindrical or substantially cylindrical. Moreover, in atleast one example embodiment, the reduced thickness at the valve pads2625 reduces or prevents softened material from the first and secondbody portions 2632A, 2632B from flowing into the flow region 2680 duringS2670D. In contrast, other forming and welding techniques may cause thecross-sectional shape of a flow region to have a non-circular shape.Specifically, the cross-sectional shape may include gaps between thefirst and second body portions 2632A, 2632B when attached to oneanother. This gapped welding may result in a cross-sectional geometrythat is difficult, if not impossible, to reliably seal or close usingvalves (e.g., valves 320A, 320B, 320C of FIG. 3A). In at least oneexample embodiment, by providing a circular cross-sectional jointbetween the layers of the soft cassette 2600, as described herein, thevalve path regions 2624 can be reliably and repeatably closed and openedduring use.

In at least one example embodiment, the method further includes, afterS2670C, removing third distinct components, such as the mandrels.

In at least one example embodiment, at S2670E, the method furtherincludes forming the soft cassette 2600. The soft cassette may be formedby sealing a perimeter of the first and second body portions 2632A,2632B to form the perimeter weld 2623A. The sealing may be performed bywelding (e.g., RF welding), bonding, or otherwise affixing the first andsecond body portions 2632A, 2632B to one another.

In at least one example embodiment, a soft cassette may includedifferent or additional features and/or components. The additionalfeatures and/or components may be manufactured as described above,and/or overwelded or overmolded into the soft cassette. Examples ofcomponents/features include sensor wires, pumps, and/or optical sensingregions. In at least one example embodiment, wires may be incorporatedfor sensing or detecting of inductive properties in a flow path. Thesemeasurements may be used to determine a type of fluid in the flow path(e.g., AC, plasma, red blood cell content, etc.). In at least oneexample embodiment, optical sensing regions may include one or moresmoothed regions (e.g., that are non-opaque, translucent, transparent,and/or light transmissive, etc.) where an optical sensor may measure acolor of a fluid in, or passing through, the soft cassette.

FIG. 25M is a perspective view of another soft cassette according to atleast one example embodiment.

In at least one example embodiment, as shown in FIG. 25M, a softcassette 2600′ is provided. The soft cassette 2600′ is the same as thesoft cassette 2600 of FIGS. 25A-25H, except that it further includes aninductive sensor 2690, an optical sensor region 2692, and a pump 2694.Features of the soft cassette 2600′ that are the same as features of thesoft cassette 2600 use the same reference number followed by the primesymbol. In at least one example embodiment, the soft cassette 2600′includes a body 2602′, a direct flow lumen 2610′, a chamber 2614′, and abypass flow lumen 2616′.

In at least the example embodiment shown, the inductive sensor 2690 isoperatively connected to the chamber 2614′. The inductive sensor 2690may include first and second sensor leads 2690A, 2690B. In at least theexample embodiment shown, the optical sensor region 2692 is operativelyconnected to the direct flow lumen 2610′. In at least the exampleembodiment shown, the pump 2694 is a roller pump including a firstportion 2694A and a second 2694B. The pump 294 may be operativelyconnected to the bypass flow lumen 2616′.

The soft cassette 2600 is shown in a particular configuration (or shownto have a particular shape/design), but it should be appreciated thatthis is one of many possible configurations/shapes/designs.

Exemplary aspects are directed to a soft cassette, comprising: a body; afirst cassette port disposed in the body; a second cassette portdisposed in the body; a direct flow lumen disposed in the body andfluidly connected to the first cassette port and the second cassetteport; a drip chamber disposed in the direct flow lumen such that fluidpassing through the direct flow lumen passes through the drip chamber; afluid flow bypass path disposed both fluidly connected to the directflow lumen adjacent the first cassette port and between the firstcassette port and the drip chamber and fluidly connected to the directflow lumen adjacent the second cassette port and between the secondcassette port and the drip chamber, such that fluid flowing through thefluid flow bypass path bypasses the drip chamber; and a fluid pressurechamber disposed in the body along a length of the fluid flow bypasspath, wherein the fluid pressure chamber comprises a first side and asecond side disposed opposite the first side, wherein a first magneticdisk is arranged on the first side of the fluid pressure chamber,wherein a second magnetic disk is arranged on the second side of thefluid pressure chamber, and wherein a space comprising a portion of thefluid flow bypass path is disposed in the fluid pressure chamber betweenthe first side and the second side.

Any one or more of the above aspects wherein the body further comprises:a first sheet arranged on a first side of the body; and a second sheetarranged on a second side of the body disposed opposite the first sideof the body; wherein a first half of the direct flow lumen, a first halfof the drip chamber, and a first half of the fluid pressure chamber areformed in the first sheet, wherein a second half of the direct flowlumen, a second half of the drip chamber, and a second half of the fluidpressure chamber are formed in the second sheet, and wherein the firstsheet is attached to the second sheet such that the first half of thedirect flow lumen opposes the second half of the direct flow lumen, thefirst half of the drip chamber opposes the second half of the directflow lumen, and the first half of the fluid pressure chamber opposes thesecond half of the fluid pressure chamber. Any one or more of the aboveaspects wherein the first magnetic disk is arranged on an outside of thefluid pressure chamber and the first sheet at the first side of thefluid pressure chamber, wherein the second magnetic disk is arranged onan outside of the fluid pressure chamber and the second sheet at thesecond side of the fluid pressure chamber. Any one or more of the aboveaspects further comprising: a first disk cover sheet attached to thefirst sheet over the first magnetic disk at the first side of the fluidpressure chamber trapping the first magnetic disk between the firstsheet and the first disk cover. Any one or more of the above aspectsfurther comprising: a second disk cover sheet attached to the firstsheet over the second magnetic disk at the second side of the fluidpressure chamber trapping the second magnetic disk between the secondsheet and the second disk cover. Any one or more of the above aspectswherein the first magnetic disk comprises a metal that is capable ofbeing magnetized. Any one or more of the above aspects wherein the spaceis unobstructed between the first side of the fluid pressure chamber andthe second side of the fluid pressure chamber, and wherein at least oneof the first side of the fluid pressure chamber and the second side ofthe fluid pressure chamber is moveable between a first state and asecond state based on a pressure inside the fluid pressure chamber. Anyone or more of the above aspects wherein, in the first state, a firstdimension is defined between the first magnetic disk and the secondmagnetic disk, wherein, in the second state, a second dimension isdefined between the first magnetic disk and the second magnetic disk,and wherein the second dimension is larger than the first dimension. Anyone or more of the above aspects wherein, in the first state, a firstpressure is defined in the fluid pressure chamber, wherein, in thesecond state, a second pressure is defined in the fluid pressurechamber, and wherein the second pressure is greater than the firstpressure.

Exemplary aspects are directed to a soft cassette assembly, comprising:a base plate having a plurality of receiving spaces formed therein; apressure sensor arranged adjacent the base plate; a first magnetarranged in contact with the pressure sensor and disposed in a firstreceiving space of the plurality of receiving spaces; an access doorpivotally attached to the base plate; a second magnet disposed in theaccess door, wherein, when the access door is closed relative to thebase plate, the first magnet and the second magnet are offset from andopposing one another; and a soft cassette attached to the base plate,the soft cassette comprising: a body comprising a first sheet arrangedon a first side of the body and a second sheet arranged on a second sideof the body disposed opposite the first side of the body; a fluidpressure chamber disposed in the body, wherein the fluid pressurechamber comprises a first side and a second side disposed opposite thefirst side, wherein a first magnetic disk is arranged on the first sideof the fluid pressure chamber, wherein a second magnetic disk isarranged on the second side of the fluid pressure chamber, and wherein aspace is disposed in the fluid pressure chamber between the first sideand the second side; wherein the second magnetic disk is magneticallycoupled to the first magnet, and wherein the first magnetic disk ismagnetically coupled to the second magnet when the access door isclosed.

Example Blood Component Collection Set with Integrated Safety Features

FIG. 26A is a perspective view of a separation set in a packaged stateaccording to at least one example embodiment. FIG. 26B is an elevationview of the separation set of FIG. 26A in the packaged configurationaccording to at least one example embodiment.

In at least one example embodiment, as shown in FIGS. 26A-26B, aseparation set 2700 or component collection set includes one or morefeatures to facilitate correct and/or safe use of the separation set2700 in an apheresis system (see, e.g., apheresis system 200 of FIG.1A). The separation set 2700 may be the same as or similar to thecollection set 500 (shown in FIG. 5A). In a packaged configuration, theseparation set 2700 may be folded and/or coiled and secured with one ormore bands or tapes 2702.

FIG. 26C is a schematic view of a separation assembly including theseparation set of FIG. 26A according to at least one example embodiment.

In at least one example embodiment, a separation assembly 2710 includesthe separation set 2700, a first media or anticoagulant (AC) bag 2712, asecond media or saline bag 2714, and a collection vessel or plasmabottle 2716. The separation set 2700 includes a soft cassette 2718, abladder 2720, first or AC tubing 2724, cassette inlet tubing 2726, loopinlet tubing 2728, a component collection loop 2730, loop exit tubing2732, second or saline tubing 2734, and third or plasma tubing 2736.

The separation set 2700 may further include a first connector 2738, asecond connector 2740, and a third connector 2742. The first connector2738 may fluidly connect the AC tubing 2724 and the cassette inlettubing 2726 to feed tubing (not shown). The second connector 2740 mayfluidly connector the component collection loop 2730, the loop exittubing 2732, and the loop inlet tubing 2728. The third connector 2742may fluidly connect the loop exit tubing 2732, the saline tubing 2734,and the plasma tubing 2736.

In at least one example embodiment, the separation set 2700 furtherincludes a first or AC tube fitting, spike, or connector 2744A, a secondor saline tube fitting, spike, or connector 2746A, and a third or plasmatube fitting, spike, or connector 2748A. The AC tube fitting 2744A isconfigured to engage a mating first receptacle 2744B of the AC bag 2712.The saline tube fitting 2746A is configured to engage a mating secondreceptacle 2746B of the saline bag 2714. The plasma tube fitting 2748Ais configured to engage a mating third receptacle 2748B of the plasmabottle 2716.

FIG. 26D is a schematic view of an apheresis system including a properlyinstalled component collection assembly according to at least oneexample embodiment. FIG. 26E is a partial perspective view of a valvehousing of the apheresis system of FIG. 26D according to at least oneexample embodiment.

In at least one example embodiment, as shown in FIG. 26D, an apheresissystem 2750 includes a housing 2752, a soft cassette assembly 2754, anaccess panel 2756 configured to provide access to a centrifuge in thehousing 2752, an AC pump 2758, a draw pump 2760, a return pump 2762, anda fluid valve control system 2764. The housing 2752, the soft cassetteassembly 2754, the access panel 2756, the AC pump 2758, the draw pump2760, the return pump 2762, and the fluid valve control system 2764 maybe similar to or the same as the housing 204, the soft cassette assembly300, the access panel 224, the AC pump 216, the draw pump 208, thereturn pump 212, and the fluid valve control system 228 of FIG. 2A.

In at least one example embodiment, in an installed state, the softcassette 2718 is in the soft cassette assembly 2754, the bladder 2720(shown in FIG. 26C) is in the centrifuge, and the third connector 2742is in the fluid valve control assembly 2764. In at least one exampleembodiment, as shown in FIG. 26E, the fluid valve control assembly 2746includes a valve housing 2766. The valve housing 2766 may at leastpartially define a connector receptacle. The connector receptacle may beconfigured to receive the third connector 2742. In at least one exampleembodiment, the connector receptacle is configured to receive the thirdconnector 2742 in only a predetermined (or alternatively, desired)orientation. In the predetermined orientation, the saline tubing 2734 isorientated toward the saline bag 2714 and closer to the saline bag 2714than the plasma bottle 2716. In the predetermined orientation, theplasma tubing 2736 is oriented toward the plasma bottle 2716 and closerto the plasma bottle 2716 than the saline bag 2714. Accordingly, theconnector receptacle may facilitate proper orientation of the separationset 2700 in the apheresis system 2750.

Returning to FIG. 26D, in at least one example embodiment, when theseparation set 2700 is in the installed state, the AC and saline tubing2724, 2734 may be configured to reach only the desired respective mediabag 2712, 2714. The AC tubing 2724 may be configured to reach the firstreceptacle 2744B of the AC bag, but not the second receptacle 2746B ofthe saline bag 2714. The saline tubing 2734 may be configured to reachthe second receptacle 2746B of the saline bag 2714, but not the firstreceptacle 2744B of the AC bag. In at least one example embodiment, theAC tubing 2724 may define a first length and the saline tubing 2734 maydefine a second length. The first and second lengths may be different.In at least one example embodiment, the first length is longer than thesecond length.

FIG. 26D is a schematic view of an apheresis system including a properlyinstalled component collection assembly according to at least oneexample embodiment. FIG. 26E is a partial perspective view of a valvehousing of the apheresis system of FIG. 26D according to at least oneexample embodiment.

With reference to FIG. 26E, in at least one example embodiment, when thesoft cassette 2718 is in the soft cassette assembly 2754, the bladder2720 (shown in FIG. 26C) is in the centrifuge, and/or the thirdconnector 2742 is in the fluid valve control assembly 2764, the firstand second lengths of the AC and saline tubing 2724, 2734, respectively,may reduce or prevent the occurrence of incorrectly connecting the tubesto the media bags 2712, 2714. As shown, the AC tubing 2724 is not longenough to reach the second receptacle 2746B of the saline bag 2714 andthe saline tubing 2734 is not long enough to reach the first receptacle2744B of the AC bag 2712. In at least one example embodiment, the abovefeatures may reduce or prevent misconnection of the tubing 2724, 2734when installed in the apheresis system 2750. Accordingly, the featuresmay reduce or prevent excessive citrate reactions in a donor, whichcould cause hypocalcemia, cardiac arrhythmia, and/or other health issuesin the donor.

Returning to FIG. 26C, the tube fittings 2744A, 2746A and the respectivereceptacles 2744B, 2746B may be configured to reduce or preventconnection to the incorrect bags 2714, 2712. In at least one exampleembodiment the tube fittings 2744A, 2746A may be color coded to providevisual indicia of proper connectivity. For example, a first color of theAC tube fitting 2744A may be the same as or similar to a color of thefirst receptacle 2744B and/or at least a portion of the AC bag 2712(e.g., graphics and/or lettering on the AC bag 2712). A second color ofthe saline tube fitting 2746A may be the same as or similar to a colorof the second receptacle 2746B and/or at least a portion of the salinebag 2714 (e.g., graphics and/or lettering on the saline bag 2714). Thefirst and second colors may be different. In at least one exampleembodiment, the first color is red and the second color is white.

In at least one other example embodiment, the tube fittings 2744A, 2746Aare shaped and/or keyed to reduce or prevent connection to incorrectmedia bags 2714, 2712. The first tube fitting 2744A may be shaped and/orkeyed to engage the first receptacle 2744B, but not the secondreceptacle 2746B of the saline bag 2714. The second tube fitting 2746Amay be shaped and/or keyed to engage the second receptacle 2746B, butnot the first receptacle 2744B. that is, the tube fittings 2744A, 2746Amay be physically incapable of fitting into the incorrect receptacle2746B, 2744B. In at least one example embodiment, the second tubefitting 2746A is a spike and the first tube fitting 2744A is anISO18250-8 connector.

FIG. 26G is a schematic view of an AC bag of the separation assembly ofFIG. 26C according to at least one example embodiment. FIG. 26H is aschematic view of a saline bag of the separation assembly of FIG. 26Caccording to at least one example embodiment.

In at least one example embodiment, as shown in FIG. 26G, the AC bag2712 includes a first body 2770A that at least partially defines a firstinterior region 2770B. The first interior region 2770B may contain ACmedia 2770C. The first body 2770A may further define a first hangeraperture 2770D. The first hanger aperture 2770D may have a first size, afirst shape, and a first dimension, such as a first length 2770E. Thefirst body 2770A may be coupled to the first receptacle 2744B.

In at least one example embodiment, as shown in FIG. 26H, the saline bag2714 includes a second body 2772A that at least partially defines asecond interior region 2772B. The second interior region 2772B maycontain saline media 2772C. The second body 2772A may further define asecond hanger aperture 2772D. The second hanger aperture 2772D may havea second size, a second shape, and a second dimension, such as a secondlength 2772E. The second body 2772A may be coupled to the secondreceptacle 2746B.

In at least one example embodiment, as described above in the discussionaccompanying FIGS. 21A-21E, the bags 2712, 2714 may be configured withvisual and/or physical features to facilitate hanging on the correctstand. Accordingly, the first and second hanger apertures 2770D, 2772Dmay differ in terms of size, shape, and/or dimension(s). In at least theexample embodiment shown, the second hanger aperture is larger than thefirst hanger aperture. The second length is longer than the firstlength. In at least one example embodiment, if an operator of theapheresis system 2750 attempts to hang the AC bag 2712 on a salinehanger, the saline hanger would be too large to fit through the firstaperture 2770D. If the operator attempts to hang the saline bag 2714 onan AC hanger, the second hanger aperture 2772D would be much larger thanthe AC hanger and should provide a visual indication that theinstallation is incorrect.

FIG. 26I is perspective view of a vessel in a cradle of the apheresissystem of FIG. 26D according to at least one example embodiment. FIG.26J is a side elevation view of the vessel and cradle of FIG. 26I.

In at least one example embodiment, the apheresis system 2750 (shown inFIG. 26D) includes a cradle 2780 for retaining the plasma bottle 2716 ina desired orientation. The plasma bottle 2780 may be similar to or thesame as the bottle 1900 of FIG. 19A. The cradle 2780 may the similar toor the same as the cradle 1516 of FIGS. 15K-15M. Accordingly, the cradle2780 may include a first end wall 2780A, a second end wall 2780B, avessel region 2780C, a cradle cap 2780D, alignment surfaces 2780E, analignment region 2780F, and a slot 2780H.

In at least one example embodiment, the bottle 2716 includes a cap2782A. The cap 2782A may include a protrusion 2782B including a pair ofbottle alignment surfaces 2782C, a pair of side surfaces 2782D, and anopposing surfaces 2782E. The cap 2782A may further include a port 2782F.The bottle 2716 may extend along a longitudinal axis 2782G.

In at least one example embodiment, when the bottle 2716 is properlyoriented in the cradle 2780, the protrusion 2782B is at least partiallywithin the alignment region 2780F. The alignment surfaces 2780E of thecradle 2780 engage (e.g., are in direct contact with) the vesselalignment surfaces 2782C and the port 2782F is at least partially withinthe slot 2780H. In at least one example embodiment, the bottle alignmentsurfaces 2780F are configured to engage the vessel alignment surfaces2780F to reduce or prevent rotation of the bottle 2716 about thelongitudinal axis 2782G. Accordingly, the cradle 2780 is configured toretain the bottle 2716 in a desired angular orientation. When the bottle2716 is in an improper orientation within the cradle 2780, the opposingsurface 2782E of the cap 2782A may engage one or both of the cradlealignment surfaces 2780F, thereby preventing the protrusion 2782B frombeing in the alignment region 2780G.

In at least one example embodiment, the cap 2782A further defines aplanar region 2782H. The planar region 2782H may be concentricallyaround and/or radially outside of the protrusion 2782A. As shown in FIG.26J, the bottle 2716 defines a first length 2786A parallel to thelongitudinal axis 2782G at a first radial location and/or intersectingthe planar region 2782H. The bottle 2716 defines a second length 2786Bat a second radial location different from the first radial locationand/or intersecting the protrusion 2782B. An interior region of thecradle 2780 defines a third length 2788. The third length 2788 is longerthan the first length 2786A, but shorter than the second length 2786B.Accordingly, the bottle 2716 only fits in the cradle 2780 in theorientation shown, with the cap 2782A of the bottle 2716 adjacent toand/or engaging the first end wall 2780A of the cradle 2780 and theprotrusion 2782B of the bottle 2716 at least partially in the alignmentregion 2780G of the cradle 2780. In contrast, if the cap 2782A wereplaced adjacent to the second end wall 2780B, the bottle 2716 would betoo long to sit fully within the cradle 2780 because the second length2786B is greater than the third length 2788.

In at least one example embodiment, the bottle 2716 includes an indicum,such as a label 2792. The bottle 2716 may be determined to be in acorrect orientation when the indicum is in a predetermined (oralternatively, desired) orientation. In at least the example embodimentshown, the bottle 2716 is correctly angularly oriented within the cradle2780 when the label 2792 faces upward.

Embodiments include a system for separating a component from amulti-component fluid comprising: a housing comprising an access doorand a top cover, the access door providing access to a chamber; acentrifuge housed in the chamber and configured to receive themulti-component fluid, the centrifuge configured to rotate to separatethe component the multi-component fluid; a first fluid bag and a secondfluid bag; and a first hook configured to support the first fluid bagand a second hook configured to support the second fluid bag, whereinthe first hook is shaped to receive the first fluid bag and the secondhook is shaped to receive the second fluid bag.

Aspects of the system further comprise a first tubing configured tocouple to the first fluid bag and a second tubing configured to coupleto the second fluid bag, wherein the first tubing has a first length andthe second tubing has a second length different than the first length,and wherein the first tubing reaches the first fluid bag and not thesecond fluid bag and the second tubing reaches the second fluid bag andnot the first fluid bag. Aspects of the system include the first tubingcomprising a first connector and the second tubing comprising a secondconnector, wherein the first connector is a first color and the secondconnector is a second color different from the first color. Aspects ofthe system include the first fluid bag comprising a first receiverconfigured to receive the first connector and the second fluid bagcomprising a second receiver configured to receive the second connector,wherein the first receiver is shaped to receive the first connector andthe second receiver is shaped to receive the second connector. Aspectsof the system further comprise a third tubing, wherein the second tubingand the third tubing are connected via a y-connector. Aspects of thesystem include the housing further comprising a valve housing disposedon the top cover, and wherein the valve housing is configured to receivethe y-connector. Aspects of the system further comprise a plasmacollection bottle and a holder configured to receive the plasmacollection bottle, wherein the holder is disposed on the top cover.Aspects of the system include the plasma collection bottle beingasymmetrical and the holder is shaped to receive the plasma collectionbottle in a specific configuration. Aspects of the system include theplasma collection bottle comprising an indicator, wherein the indicatorfaces a predetermined direction when the plasma collection bottle isproperly loaded in the holder. Aspects of the system include the firsttubing configured to transport anticoagulant fluid, the second tubingconfigured to transport saline, and the third tubing configured totransport plasma.

The exemplary systems and methods of this disclosure have been describedin relation to apheresis methods and systems. However, to avoidunnecessarily obscuring the present disclosure, the precedingdescription omits a number of known structures and devices. Thisomission is not to be construed as a limitation of the scope of theclaimed disclosure. Specific details are set forth to provide anunderstanding of the present disclosure. It should, however, beappreciated that the present disclosure may be practiced in a variety ofways beyond the specific detail set forth herein.

Furthermore, while the exemplary aspects, embodiments, and/orconfigurations illustrated herein show the various components of thesystem collocated, certain components of the system can be locatedremotely, at distant portions of a distributed network, such as a LANand/or the Internet, or within a dedicated system. Thus, it should beappreciated, that the components of the system can be combined into oneor more devices, such as the cassette node 904 and the centrifuge node908, or collocated on a particular node of a distributed network, suchas an analog and/or digital telecommunications network, a packet-switchnetwork, or a circuit-switched network. It will be appreciated from thepreceding description, and for reasons of computational efficiency, thatthe components of the system can be arranged at any location within adistributed network of components without affecting the operation of thesystem. For example, the various components can be located in a switchsuch as a PBX and media server, gateway, in one or more communicationsdevices, at one or more users' premises, or some combination thereof.Similarly, one or more functional portions of the system could bedistributed between a telecommunications device(s) and an associatedcomputing device.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

What is claimed is:
 1. A soft cassette comprising: a body comprising aflexible material, the body defining, a first lumen extending between afirst end and a second end, a first chamber in the first lumen such thatfluid passing through the first lumen passes through the first chamber,a second lumen fluidly connected to the first lumen at a first junctionbetween the first end and the first chamber and a second junctionbetween the second end and the first chamber such that fluid passingthrough the second lumen bypasses the first chamber, and a secondchamber in the second lumen; a first component on a first side of thesecond chamber, the first component comprising a first ferromagneticmetal or a first magnet; and a second component on a second side of thesecond chamber, the second component comprising a second ferromagneticmetal or a second magnet.
 2. The soft cassette of claim 1, wherein thebody includes a first side and a second side, the first side and thesecond side cooperate to define the first lumen, the first chamber, thesecond lumen, and the second chamber.
 3. The soft cassette of claim 2,wherein the body defines a first center plane between the first side andthe second side, and the first chamber is reflection asymmetric aboutthe first center plane.
 4. The soft cassette of claim 3, wherein thefirst chamber is reflection asymmetric about a second center planeperpendicular to the first center plane.
 5. The soft cassette of claim1, wherein the body defines an orthogonal coordinate system including afirst axis, a second axis, and a third axis, a center of the firstchamber is offset from a center of the second chamber along the firstaxis and the second axis.
 6. The soft cassette of claim 1, wherein thebody further defines a first valve path in the first lumen or the secondlumen, the first valve path defining a circular cross section.
 7. Thesoft cassette of claim 6, wherein the body defines a first region and asecond region, the second region including the first valve path thefirst region defines a first thickness, the second region defines asecond thickness adjacent to the first valve path, the second thicknessbeing less than the first thickness.
 8. The soft cassette of claim 6,wherein the body further defines a plurality of valve paths including,the first valve path between a first end of the first chamber and afirst end of the second lumen, a second valve path between a second endof the first chamber and a second end of the second lumen, and a thirdvalve path between the first end of the second lumen and the secondchamber.
 9. The soft cassette of claim 1, further comprising: a filterin the first chamber.
 10. The soft cassette of claim 9, furthercomprising: a first port fluidly connected to the first end of the firstlumen; and a second port fluidly connected to the second end of thefirst lumen.
 11. The soft cassette of claim 10, wherein the first portand the second port define distinct shapes, colors, or both shapes andcolors.
 12. The soft cassette of claim 11, wherein only one of the firstport and the second port defines a radially-extending flange.
 13. Thesoft cassette of claim 1, further comprising: a first tube in the firstlumen between the first end and the first chamber, and a second tube inthe first lumen between the second end and the first chamber.
 14. Thesoft cassette of claim 1, further comprising: a first cover cooperatingwith the body to define a first pocket; and a second cover cooperatingwith the body to define a second pocket, wherein the first component isin the first pocket and the second component is in the second pocket.15. The soft cassette of claim 1, wherein a region between the firstside of the second chamber and the second side of the second chamber isunobstructed, at least one of the first side of the second chamber andthe second side of the second chamber is configured to move between afirst state and a second state based on a pressure in the secondchamber.
 16. The soft cassette of claim 15, wherein in the first state,the second chamber defines a first pressure and a first dimension isdefined between the first component and the second component, in thesecond state, the second chamber defines a second pressure and a seconddimension is defined between the first component and the secondcomponent, the second pressure is larger than the first pressure, andthe second dimension is larger than the first dimension.
 17. A softcassette assembly comprising: a base plate defining a plurality ofreceiving regions; a door attached to the base plate; a first magnetcoupled to the base plate; a second magnet coupled to the door; apressure sensor in contact with the first magnet or the second magnet;and a soft cassette configured to be attached to the base plate, thesoft cassette including, a body defining, a first lumen extendingbetween a first end and a second end, a first chamber in the first lumensuch that fluid passing through the first lumen passes through the firstchamber, a second lumen fluidly connected to the first lumen at a firstjunction between the first end and the first chamber and a secondjunction between the second end and the first chamber such that fluidpassing through the second lumen bypasses the first chamber, and asecond chamber in the second lumen; a first component on a first side ofthe second chamber, the first component comprising a first ferromagneticmetal, the first component being configured to be coupled to the firstmagnet; and a second component on a second side of the second chamber,the second component comprising a second ferromagnetic material, thesecond component being configured to be coupled to the second magnet.18. A method of manufacturing a soft cassette, the method comprising:forming a first side of a soft cassette body from a first thermoplasticsheet portion; forming a second side of the soft cassette body from asecond thermoplastic sheet portion; fixing the first side to the secondside to at least partially define a first lumen extending between afirst end and a second end, a first chamber in the first lumen, a secondlumen fluidly connected to the first lumen at a first junction betweenthe first end and the first chamber and a second junction between thesecond end and the first chamber, and a second chamber in the secondlumen; and creating the soft cassette by sealing a perimeter of thefirst side and the second side.
 19. The method of claim 18, furthercomprising: coupling a first component to the first side, the firstcomponent including a first ferromagnetic metal or a first magnet. 20.The method of claim 19, wherein the coupling includes, disposing thefirst component between the first side and a cover, and fixing the coverto the first side to define a pocket, the first component being in thepocket.
 21. The method of claim 20, wherein the fixing includesradiofrequency welding the cover to the first side around a periphery ofthe cover.
 22. The method of claim 19, further comprising: coupling asecond component to the second side, the second component including asecond ferromagnetic metal or a second magnet.
 23. The method of claim18, wherein the forming the first side and the forming the second sideare performed concurrently.
 24. The method of claim 18, wherein theforming the first side, the forming the second side, the fixing, and thecreating are performed using radio frequency energy.
 25. The method ofclaim 18, wherein the forming the first side includes forming a firstvalve region, the first valve region having a smaller thickness than afirst body region of the first side, the forming the second sideincludes forming a second valve region, the second valve region having asmaller thickness than a second body region of the second side, and thefixing further includes at least partially defining a valve path betweenat least a portion of the first valve region and at least a portion ofthe second valve region.
 26. The method of claim 25, further comprising:prior to the fixing, disposing a cylindrical mandrel between the firstvalve region and the second valve region, after the fixing, removing thecylindrical mandrel such that the valve path is between the first valveregion and the second valve region and the valve path defines a circularcross section.
 27. The method of claim 18, further comprising: prior tothe fixing, disposing a distinct component at least partially betweenthe first side and the second side, the distinct component including afilter, a tube, a port, a pump, or any combination thereof, wherein thefixing secures the distinct component between the first side and thesecond side.
 28. The method of claim 27, further comprising: prior tothe fixing, folding a sheet including the first side and the second sidesuch that the first side is in direct contact with the second side.